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00:00:00 2929 1 020634 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s033,034,20635s033,034ltr.pdf 2004-09-15 00:00:00 2930 1 020634 SUPPL 35 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20634s035,20635s035,21721s003ltr.pdf 2004-12-02 00:00:00 2931 1 020634 SUPPL 36 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20635s037,20634s036ltr.pdf 2004-11-08 00:00:00 2932 1 020634 SUPPL 42 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s042,020635s045,021721s010ltr.pdf 2007-06-04 00:00:00 2933 1 020634 SUPPL 44 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s044,020635s047,021721s012ltr.pdf 2007-05-16 00:00:00 2934 1 020634 SUPPL 45 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s045, 020635s048, 021721s013ltr.pdf 2007-07-05 00:00:00 2935 1 020634 SUPPL 48 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020634s048,020635s052,021721s016ltr.pdf 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020764s029ltr.pdf 2009-05-13 00:00:00 3292 1 020764 SUPPL 31 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf 2009-05-04 00:00:00 3293 1 020764 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf 2013-12-26 00:00:00 3294 1 020764 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 2015-01-07 00:00:00 3295 1 020764 SUPPL 38 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 2015-03-25 00:00:00 3296 1 020766 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20766se5-018ltr.pdf 2003-12-19 00:00:00 3297 1 020766 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020766s026ltr.pdf 2009-02-18 00:00:00 3298 1 020766 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020766s028ltr.pdf 2010-05-25 00:00:00 3299 1 020766 SUPPL 29 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020766s029ltr.pdf 2012-01-25 00:00:00 3300 1 020766 SUPPL 35 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020766Orig1s035ltr.pdf 2015-08-11 00:00:00 3301 1 020768 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf 2003-06-08 00:00:00 3302 1 020768 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20768s012ltr.pdf 2004-11-19 00:00:00 3303 1 020768 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf 2004-01-14 00:00:00 3304 1 020768 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020768s017ltr.pdf 2010-08-16 00:00:00 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1998-04-09 00:00:00 3313 1 020772 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020772s002ltr.pdf 2006-11-07 00:00:00 3314 1 020772 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020772s005ltr.pdf 2014-03-10 00:00:00 3315 1 020774 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20774ltr.pdf 1998-05-15 00:00:00 3316 1 020774 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020774s010ltr.pdf 2011-06-14 00:00:00 3317 1 020774 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020774Orig1s012ltr.pdf 2012-11-09 00:00:00 3318 1 020776 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020776Orig1s006ltr.pdf 2016-05-12 00:00:00 3319 1 020778 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf 2002-02-05 00:00:00 3320 1 020778 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20779s37s38ltr.pdf 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20939ltr.pdf 2000-01-28 00:00:00 3813 1 020941 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020941s006ltr.pdf 2007-05-29 00:00:00 3814 1 020941 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020941s009ltr.pdf 2008-02-14 00:00:00 3815 1 020943 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020943s007s026ltr.pdf 2010-04-09 00:00:00 3816 1 020943 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020943s020ltr.pdf 2007-05-07 00:00:00 3817 1 020943 SUPPL 29 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020943Orig1s029ltr.pdf 2014-10-14 00:00:00 3818 1 020944 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20944_Advil_Approv.pdf 1998-12-18 00:00:00 3819 1 020944 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20944s002,003ltr.pdf 2004-12-30 00:00:00 3820 1 020944 SUPPL 6 0 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00:00:00 3828 1 020945 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020945s032ltr.pdf 2011-12-08 00:00:00 3829 1 020945 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s033ltr.pdf 2012-04-02 00:00:00 3830 1 020945 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s034ltr.pdf 2012-02-23 00:00:00 3831 1 020945 SUPPL 35 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945Orig1s035ltr.pdf 2012-11-21 00:00:00 3832 1 020945 SUPPL 40 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s040ltr.pdf 2015-11-13 00:00:00 3833 1 020946 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20946ltr.pdf 1998-09-01 00:00:00 3834 1 020947 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf 2010-03-31 00:00:00 3835 1 020947 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011ltr.pdf 2016-05-11 00:00:00 3836 1 020949 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020949s011LTR.pdf 2006-06-06 00:00:00 3837 1 020950 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020950s018ltr.pdf 2005-10-20 00:00:00 3838 1 020950 SUPPL 37 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020950s037ltr.pdf 2012-05-31 00:00:00 3839 1 020954 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20954ltr.pdf 1999-02-04 00:00:00 3840 1 020954 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954slr001ltr.pdf 2002-12-23 00:00:00 3841 1 020954 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954s003.pdf 2002-04-24 00:00:00 3842 1 020954 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf 2011-06-29 00:00:00 3843 1 020954 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020954Orig1s014ltr.pdf 2015-01-20 00:00:00 3844 1 020955 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20955s3ltr.pdf 2003-07-23 00:00:00 3845 1 020955 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20955s006ltr.pdf 2004-08-25 00:00:00 3846 1 020958 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20958ltr.pdf 2000-10-16 00:00:00 3847 1 020958 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20958slr007ltr.pdf 2003-11-13 00:00:00 3848 1 020958 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020958s012ltr.pdf 2005-07-21 00:00:00 3849 1 020958 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020958s013LTR.pdf 2006-06-12 00:00:00 3850 1 020958 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020958s015ltr.pdf 2008-11-18 00:00:00 3851 1 020963 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20963ltr.pdf 1998-10-21 00:00:00 3852 1 020963 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020963s010ltr.pdf 2007-06-14 00:00:00 3853 1 020965 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20965ltr.pdf 1999-12-07 00:00:00 3854 1 020965 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20965scm004ltr.pdf 2003-07-28 00:00:00 3855 1 020965 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020965s006ltr.pdf 2009-11-20 00:00:00 3856 1 020965 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020965s007ltr.pdf 2010-03-18 00:00:00 3857 1 020966 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20966ltr.pdf 1999-03-30 00:00:00 3858 1 020966 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf 2001-04-17 00:00:00 3859 1 020966 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-966S001_Sporanox_Approv.pdf 2001-04-17 00:00:00 3860 1 020966 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20966slr006ltr.pdf 2002-07-17 00:00:00 3861 1 020966 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20966s011ltr.pdf 2004-07-21 00:00:00 3862 1 020966 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s017,s018,s020ltr.pdf 2009-03-10 00:00:00 3863 1 020966 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020966s022ltr.pdf 2009-04-27 00:00:00 3864 1 020969 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20969ltr.pdf 1999-02-25 00:00:00 3865 1 020971 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-971_Septocaine_Approv.pdf 2000-04-03 00:00:00 3866 1 020971 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20971s007ltr.pdf 2004-10-18 00:00:00 3867 1 020971 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20971s009ltr.pdf 2005-02-08 00:00:00 3868 1 020971 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s021ltr.pdf 2010-02-26 00:00:00 3869 1 020971 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020971s023ltr.pdf 2010-11-18 00:00:00 3870 1 020972 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972s7ltr.pdf 2002-03-01 00:00:00 3871 1 020972 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr016ltr.pdf 2003-01-29 00:00:00 3872 1 020972 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf 2002-09-20 00:00:00 3873 1 020972 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf 2003-06-22 00:00:00 3874 1 020972 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr.pdf 2004-10-29 00:00:00 3875 1 020972 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf 2006-04-05 00:00:00 3876 1 020972 SUPPL 29 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029, 021360s016ltr.pdf 2007-02-02 00:00:00 3877 1 020972 SUPPL 36 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf 2010-12-03 00:00:00 3878 1 020972 SUPPL 40 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf 2011-12-21 00:00:00 3879 1 020972 SUPPL 41 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029ltr.pdf 2012-06-26 00:00:00 3880 1 020972 SUPPL 43 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360Orig1s031ltr.pdf 2013-05-07 00:00:00 3881 1 020973 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s012ltr.pdf 2002-05-29 00:00:00 3882 1 020973 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973scf015ltr.pdf 2002-09-30 00:00:00 3883 1 020973 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20973slr016ltr.pdf 2003-08-15 00:00:00 3884 1 020973 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020973se5-022ltr.pdf 2008-07-02 00:00:00 3885 1 020973 SUPPL 25 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020973s025ltr.pdf 2010-09-08 00:00:00 3886 1 020973 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973s030ltr.pdf 2012-05-10 00:00:00 3887 1 020973 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020973Orig1s032ltr.pdf 2013-04-23 00:00:00 3888 1 020973 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf 2016-04-06 00:00:00 3889 1 020973 SUPPL 35 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf 2014-12-24 00:00:00 3890 1 020974 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018936s71,018936s73,020101s32,020974s05,021235s03ltr.pdf 2005-12-05 00:00:00 3891 1 020974 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18936s072,20101s033,20974s006,21235s004ltr.pdf 2005-02-23 00:00:00 3892 1 020974 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018936s074, 020101s034, 020974s007, 021235s006ltr.pdf 2006-04-13 00:00:00 3893 1 020975 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf 2004-06-10 00:00:00 3894 1 020975 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf 2006-08-07 00:00:00 3895 1 020975 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020975s010ltr.pdf 2008-08-20 00:00:00 3896 1 020975 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf 2007-09-06 00:00:00 3897 1 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20978ltr.pdf 1998-12-17 00:00:00 3904 1 020977 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20977slr010,20978slr012ltr.pdf 2003-07-28 00:00:00 3905 1 020977 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf 2004-04-20 00:00:00 3906 1 020977 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 2009-08-25 00:00:00 3907 1 020977 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf 2004-08-05 00:00:00 3908 1 020977 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf 2012-03-19 00:00:00 3909 1 020977 SUPPL 25 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s025,020978s029ltr.pdf 2012-05-22 00:00:00 3910 1 020977 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s027,020978Orig1s031ltr.pdf 2015-03-25 00:00:00 3911 1 020977 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s028,020978Orig1s032ltr.pdf 2015-02-24 00:00:00 3912 1 020977 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020977Orig1s030,020978Orig1s034ltr.pdf 2015-10-02 00:00:00 3913 1 020978 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20977slr008,20978slr010ltr.pdf 2002-08-14 00:00:00 3914 1 020978 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977se7-011,20978se7-013ltr.pdf 2004-04-20 00:00:00 3915 1 020978 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020977s011,020977s012,020978s013,020978s014ltr.pdf 2009-08-25 00:00:00 3916 1 020978 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20977s012,20978s014ltr.pdf 2004-08-05 00:00:00 3917 1 020978 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020977s014, 020978s016LTR.pdf 2006-08-21 00:00:00 3918 1 020978 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020977s016, 020978s019ltr.pdf 2007-05-09 00:00:00 3919 1 020978 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s017,020978s020ltr.pdf 2008-07-23 00:00:00 3920 1 020978 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020977s019, 020978s022ltr.pdf 2008-12-29 00:00:00 3921 1 020978 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020977s020,020978s024,021205s024,021652s011ltr.pdf 2010-08-10 00:00:00 3922 1 020978 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020977s022,020978s026,021205s028,021652s013ltr.pdf 2011-05-17 00:00:00 3923 1 020978 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020977s024,020978s028ltr.pdf 2012-03-19 00:00:00 3924 1 020978 SUPPL 29 0 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00:00:00 4923 1 021286 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021286s020ltr.pdf 2011-06-07 00:00:00 4924 1 021286 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021286s023ltr.pdf 2012-04-02 00:00:00 4925 1 021286 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s030ltr.pdf 2014-06-17 00:00:00 4926 1 021286 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021286Orig1s032ltr.pdf 2014-09-24 00:00:00 4927 1 021287 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021287s005ltr.pdf 2006-03-23 00:00:00 4928 1 021287 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021287s008ltr.pdf 2007-04-09 00:00:00 4929 1 021287 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021287s009ltr.pdf 2008-05-09 00:00:00 4930 1 021287 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021287s016ltr.pdf 2010-12-21 00:00:00 4931 1 021288 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21288ltr.pdf 2001-06-29 00:00:00 4932 1 021288 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020715s016, 021288s013ltr.pdf 2008-04-16 00:00:00 4933 1 021288 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020715s024,021288s021,022437s002ltr.pdf 2011-01-20 00:00:00 4934 1 021288 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020715Orig1s030,021288Orig1s027,022437Orig1s007ltr.pdf 2013-03-15 00:00:00 4935 1 021289 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21289ltr.pdf 2002-05-06 00:00:00 4936 1 021289 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021289Orig1s019ltr.pdf 2014-02-21 00:00:00 4937 1 021290 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21290se8-001ltr.pdf 2003-10-06 00:00:00 4938 1 021290 SUPPL 6 0 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2006-12-28 00:00:00 4954 1 021299 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021299s021ltr.pdf 2008-03-07 00:00:00 4955 1 021299 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021299s023ltr.pdf 2009-02-03 00:00:00 4956 1 021299 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021299s024ltr.pdf 2011-04-29 00:00:00 4957 1 021299 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021299Orig1s027,s028,s029ltr.pdf 2012-12-21 00:00:00 4958 1 021299 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021299Orig1s032ltr.pdf 2014-07-24 00:00:00 4959 1 021300 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21300ltr.pdf 2004-09-03 00:00:00 4960 1 021300 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021165s7s8s9,021300s1s3s4s5,021312s6s8s9ltr.pdf 2006-12-28 00:00:00 4961 1 021300 SUPPL 14 0 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2014-04-02 00:00:00 4969 1 021303 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall_Approv.pdf 2001-10-11 00:00:00 4970 1 021303 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21303s001ltr.pdf 2002-05-22 00:00:00 4971 1 021303 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021303s015ltr.pdf 2007-05-29 00:00:00 4972 1 021303 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf 2010-11-18 00:00:00 4973 1 021303 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s024ltr.pdf 2013-06-18 00:00:00 4974 1 021303 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021303Orig1s027ltr.pdf 2014-07-25 00:00:00 4975 1 021304 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21304ltr.pdf 2001-03-29 00:00:00 4976 1 021304 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21304se1-001ltr.pdf 2003-09-25 00:00:00 4977 1 021304 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021304s004ltr.pdf 2006-02-02 00:00:00 4978 1 021304 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022257s000_021304s07ltr.pdf 2009-09-01 00:00:00 4979 1 021304 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021304Orig1s011,022257Orig1s005ltr.pdf 2015-04-24 00:00:00 4980 1 021305 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305ltr.pdf 2003-01-24 00:00:00 4981 1 021305 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21305slr001ltr.pdf 2003-08-15 00:00:00 4982 1 021305 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21305s002ltr.pdf 2004-12-02 00:00:00 4983 1 021305 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021305s003ltr.pdf 2005-05-20 00:00:00 4984 1 021305 SUPPL 10 0 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2004-08-12 00:00:00 7831 1 050575 SUPPL 38 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf 2008-04-02 00:00:00 7832 1 050575 SUPPL 40 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 2013-01-24 00:00:00 7833 1 050575 SUPPL 42 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 2013-01-24 00:00:00 7834 1 050577 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf 2003-07-30 00:00:00 7835 1 050577 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf 2003-01-22 00:00:00 7836 1 050578 SUPPL 40 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf 2002-03-29 00:00:00 7837 1 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00:00:00 7845 1 050585 SUPPL 54 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585slr054ltr.pdf 2004-04-07 00:00:00 7846 1 050585 SUPPL 58 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s058ltr.pdf 2007-07-24 00:00:00 7847 1 050585 SUPPL 66 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s066ltr.pdf 2015-03-24 00:00:00 7848 1 050585 SUPPL 67 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s067ltr.pdf 2015-07-08 00:00:00 7849 1 050586 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050586s025_s026ltr.pdf 2006-01-19 00:00:00 7850 1 050587 SUPPL 48 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/50587sltr.pdf 1998-04-08 00:00:00 7851 1 050587 SUPPL 53 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50587s53ltr.pdf 2001-11-30 00:00:00 7852 1 050587 SUPPL 61 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf 2010-12-28 00:00:00 7860 1 050590 SUPPL 67 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658Orig1s029ltr.pdf 2013-10-01 00:00:00 7861 1 050590 SUPPL 69 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658Orig1s031ltr.pdf 2014-06-17 00:00:00 7862 1 050591 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/50591Orig1s032,50703Orig1s015,50746Orig1s018ltr.pdf 2014-05-27 00:00:00 7863 1 050592 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50592slr032ltr.pdf 2003-07-06 00:00:00 7864 1 050596 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf 2002-01-18 00:00:00 7865 1 050596 SUPPL 35 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050596s035ltr.pdf 2008-02-25 00:00:00 7866 1 050596 SUPPL 36 0 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050629 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf 2002-09-25 00:00:00 7902 1 050629 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50467slr064,067,50629slr010,013ltr.pdf 2002-09-25 00:00:00 7903 1 050629 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50629se1-014slr016,50467se1-068,slr069ltr.pdf 2003-05-30 00:00:00 7904 1 050629 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050467s070,050629s017ltr.pdf 2010-08-09 00:00:00 7905 1 050629 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050467s071,050629s019ltr.pdf 2011-09-29 00:00:00 7906 1 050629 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050629Orig1s022ltr.pdf 2013-11-06 00:00:00 7907 1 050630 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50630slr023,50587slr061ltr.pdf 2004-05-26 00:00:00 7908 1 050630 SUPPL 26 0 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00:00:00 8407 1 071881 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/071881Orig1s005ltr.pdf 2015-10-16 00:00:00 8408 1 073193 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073193Orig1s033ltr.pdf 2015-08-27 00:00:00 8409 1 073210 SUPPL 29 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073210Orig1s029ltr.pdf 2015-08-27 00:00:00 8410 1 074253 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74253S1&2ltr.pdf 2003-04-09 00:00:00 8411 1 074278 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74278ltr.pdf 2000-03-31 00:00:00 8412 1 074415 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74415ltr.pdf 1998-06-08 00:00:00 8413 1 074432 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74432ltr.pdf 1999-07-29 00:00:00 8414 1 074446 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74446ltr.pdf 2000-05-18 00:00:00 8415 1 074464 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1998-06-30 00:00:00 12387 2 020262 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf 1998-04-09 00:00:00 12388 2 020262 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20262slbl.pdf 1998-04-09 00:00:00 12389 2 020262 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20262S33LBL.PDF 1999-10-25 00:00:00 12390 2 020262 SUPPL 48 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf 2010-08-28 00:00:00 12391 2 020262 SUPPL 51 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020262s051lbl.pdf 2015-03-05 00:00:00 12392 2 020263 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf 2004-04-05 00:00:00 12393 2 020263 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf 2005-11-17 00:00:00 12394 2 020263 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf 2009-06-29 00:00:00 12395 2 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http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s009lbl.pdf 2006-02-07 00:00:00 12432 2 020304 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020304s022lbl.pdf 2006-12-15 00:00:00 12433 2 020305 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020239s021,020305s014,021238s007lbl.pdf 2009-10-14 00:00:00 12434 2 020306 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20306_FLUDEOXYGLUCOSE_prntlbl.pdf 2004-03-10 00:00:00 12435 2 020312 SUPPL 31 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020312s031lbl.pdf 2010-01-29 00:00:00 12436 2 020312 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020312s033lbl.pdf 2011-09-02 00:00:00 12437 2 020312 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s034lbl.pdf 2012-01-23 00:00:00 12438 2 020312 SUPPL 35 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020312s035lbl.pdf 2012-09-18 00:00:00 12439 2 020313 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020313s034lbl.pdf 2014-03-13 00:00:00 12440 2 020316 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf 2015-07-23 00:00:00 12441 2 020323 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf 2000-08-16 00:00:00 12442 2 020325 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20325se2-015_pepcid_lbl.pdf 2003-09-30 00:00:00 12443 2 020325 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020325Orig1s024Lbl.pdf 2016-04-11 00:00:00 12444 2 020325 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020325Orig1s030lbl.pdf 2016-06-13 00:00:00 12445 2 020326 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20326s11s13lbl.pdf 2002-06-26 00:00:00 12446 2 020326 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020326s015lbl.pdf 2005-11-17 00:00:00 12447 2 020327 SUPPL 7 0 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2003-04-30 00:00:00 17474 1 019593 SUPPL 38 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050, 019593s038_ltr.pdf 2006-07-21 00:00:00 17475 1 019593 SUPPL 39 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s051,019593s039ltr.pdf 2009-02-19 00:00:00 17476 1 019596 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf 2010-08-31 00:00:00 17477 1 019596 SUPPL 45 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019596s045,021037s019ltr.pdf 2009-05-29 00:00:00 17478 1 019599 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019599s011ltr.pdf 2012-01-18 00:00:00 17479 1 019599 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019599Orig1s012ltr.pdf 2014-10-14 00:00:00 17480 1 019614 SUPPL 45 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019614s045,s034ltr.pdf 2010-04-02 00:00:00 17481 1 019614 SUPPL 49 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19643s067ltr.pdf 2002-02-14 00:00:00 17505 1 019643 SUPPL 75 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19643s075ltr.pdf 2005-04-12 00:00:00 17506 1 019643 SUPPL 77 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019643s077ltr.pdf 2005-06-14 00:00:00 17507 1 019643 SUPPL 78 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019643s078ltr.pdf 2007-06-04 00:00:00 17508 1 019643 SUPPL 80 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019643s080ltr.pdf 2009-03-11 00:00:00 17509 1 019643 SUPPL 82 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 2011-06-17 00:00:00 17510 1 019643 SUPPL 85 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643s085ltr.pdf 2012-02-28 00:00:00 17511 1 019643 SUPPL 86 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019643Orig1s086,s087ltr.pdf 2012-11-05 00:00:00 17512 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s020.pdf 2014-07-02 00:00:00 20960 3 020788 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s021.pdf 2014-07-02 00:00:00 20961 3 020788 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s023.pdf 2014-07-02 00:00:00 20962 3 020791 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020791_testoderm_toc.cfm 2003-08-07 00:00:00 20963 3 020792 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020792ap.pdf 1997-10-07 00:00:00 20964 3 020793 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020793_000_CafcitTOC.cfm 2005-07-15 00:00:00 20965 3 020796 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20796_Comtan.cfm 1999-12-30 00:00:00 20966 3 020799 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-799_Floxin.cfm 2005-01-07 00:00:00 20967 3 020800 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020800Orig1s023.pdf 2013-10-21 00:00:00 20968 3 020801 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020801Orig1s012.pdf 2012-03-27 00:00:00 20969 3 020807 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20807_Refludan.cfm 2003-04-04 00:00:00 20970 3 020811 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020811ap.pdf 1997-11-03 00:00:00 20971 3 020812 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020812_PediatricTOC.cfm 2005-06-23 00:00:00 20972 3 020812 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020812Orig1s011.pdf 2013-04-18 00:00:00 20973 3 020815 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20815s2_Evista.pdf 1998-11-24 00:00:00 20974 3 020816 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020816_azopt.cfm 2003-06-19 00:00:00 20975 3 020819 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20819_Zemplar.cfm 1998-04-17 00:00:00 20976 3 020822 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020822a.cfm 1998-07-17 00:00:00 20977 3 020822 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020822_s019_CelexaTOC.cfm 2006-05-18 00:00:00 20978 3 020822 SUPPL 38 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf 2011-10-11 00:00:00 20979 3 020822 SUPPL 42 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020822Orig1s042.pdf 2013-09-11 00:00:00 20980 3 020823 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20823_Exelon.cfm 2000-04-21 00:00:00 20981 3 020823 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020823_S003_EXELON_AP.pdf 2007-06-18 00:00:00 20982 3 020823 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020823_016_exelon.pdf 2006-06-27 00:00:00 20983 3 020825 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020825_s021_GEODON.pdf 2008-07-30 00:00:00 20984 3 020825 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020825Orig1s034.pdf 2012-10-12 00:00:00 20985 3 020828 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020828_S006_FORTOVASE.pdf 2007-07-27 00:00:00 20986 3 020828 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020828_S015_FORTOVASE.pdf 2007-07-27 00:00:00 20987 3 020829 SUPPL 25 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S025_SINGULAIR_TABLETS_AP.pdf 2007-07-06 00:00:00 20988 3 020830 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20830_Singulair.cfm 2001-05-24 00:00:00 20989 3 020830 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20830s008_Singulair.cfm 2001-09-07 00:00:00 20990 3 020830 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf 2007-07-09 00:00:00 20991 3 020832 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-832_CHLORAPREP.cfm 2000-07-14 00:00:00 20992 3 020832 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020832_S008_CHLORAPREP_WITH_TINT.pdf 2007-12-06 00:00:00 20993 3 020834 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020834_rogaine_toc.cfm 2003-08-08 00:00:00 20994 3 020835 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm 2001-08-17 00:00:00 20995 3 020835 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20835S001_Actonel.cfm 2001-08-17 00:00:00 20996 3 020835 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S010_ACTENOL.pdf 2008-02-19 00:00:00 20997 3 020835 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S011_ACTONEL.pdf 2008-02-19 00:00:00 20998 3 020835 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020835_S012_ACTONEL.pdf 2008-02-19 00:00:00 20999 3 020837 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20837_Xenopex.cfm 1999-03-25 00:00:00 21000 3 020838 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20838_Atacand.cfm 2003-05-22 00:00:00 21001 3 020838 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20838-s008_atacand.pdf 2004-05-27 00:00:00 21002 3 020839 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020839_s000.pdf 2010-03-04 00:00:00 21003 3 020839 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-002.PDF 2005-08-04 00:00:00 21004 3 020839 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-004.PDF 2005-08-04 00:00:00 21005 3 020839 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-005.PDF 2005-08-04 00:00:00 21006 3 020839 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-013.PDF 2005-08-04 00:00:00 21007 3 020839 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-014.PDF 2005-08-04 00:00:00 21008 3 020839 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-015.PDF 2005-08-04 00:00:00 21009 3 020839 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-016.PDF 2005-08-04 00:00:00 21010 3 020839 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020-839_S-017.PDF 2005-08-04 00:00:00 21011 3 020839 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020839_s034_plavix.pdf 2006-08-17 00:00:00 21012 3 020841 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020841_Lotemax.cfm 2002-04-11 00:00:00 21013 3 020844 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020844s000_Topamax.cfm 2004-09-15 00:00:00 21014 3 020844 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S1_Topamax.cfm 2000-07-03 00:00:00 21015 3 020844 SUPPL 10 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S009_Combivar.pdf 2007-09-24 00:00:00 21024 3 020857 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S010_Combivar.pdf 2007-09-24 00:00:00 21025 3 020859 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20859_Sonata.cfm 2000-07-03 00:00:00 21026 3 020862 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020862_Hectorol.cfm 1999-06-09 00:00:00 21027 3 020863 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20863.cfm 1999-01-15 00:00:00 21028 3 020864 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf 2004-04-15 00:00:00 21029 3 020864 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020864_s008_MAXALT_TABLETS.pdf 2008-08-01 00:00:00 21030 3 020865 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-006.pdf 2004-04-21 00:00:00 21031 3 020865 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-007.pdf 2004-04-21 00:00:00 21032 3 020866 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020866_cycloset_toc.cfm 2011-10-03 00:00:00 21033 3 020868 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020868a.pdf 1997-11-26 00:00:00 21034 3 020872 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf 2004-05-26 00:00:00 21035 3 020872 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-872S004_Allegra.pdf 2004-05-26 00:00:00 21036 3 020872 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s008_ALLEGRA_TABLETS.pdf 2008-08-01 00:00:00 21037 3 020872 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020872_s009_ALLEGRA_TABLETS.pdf 2008-08-01 00:00:00 21038 3 020873 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20873_Angiomax.cfm 2004-04-08 00:00:00 21039 3 020882 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20882.cfm 1998-10-09 00:00:00 21040 3 020883 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-883_Acova.cfm 2002-04-05 00:00:00 21041 3 020885 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020885a.pdf 1998-10-09 00:00:00 21042 3 020885 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020885Orig1s004.pdf 2011-12-09 00:00:00 21043 3 020886 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20886.cfm 1999-02-02 00:00:00 21044 3 020887 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20887.cfm 1998-09-14 00:00:00 21045 3 020892 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20892.cfm 1998-09-25 00:00:00 21046 3 020895 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/NDA/98/viagra/viagra_toc.cfm 2009-04-13 00:00:00 21047 3 020895 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020895_S002_VIAGRA.pdf 2008-02-19 00:00:00 21048 3 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0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021312_s007_clarinex red-tabs.pdf 2011-02-15 00:00:00 21593 3 021314 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021314s000_IDKitTOC.cfm 2005-11-30 00:00:00 21594 3 021316 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_altocor.cfm 2003-04-30 00:00:00 21595 3 021318 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-318_Forteo.cfm 2004-03-24 00:00:00 21596 3 021319 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21319_Duagen.cfm 2001-11-20 00:00:00 21597 3 021322 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021322s000_LuverisTOC.cfm 2005-11-30 00:00:00 21598 3 021323 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXAPRO_TABS.pdf 2007-07-06 00:00:00 21599 3 021323 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXAPRO_TABS.pdf 2007-07-06 00:00:00 21600 3 021323 SUPPL 31 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021323Orig1S030_s031.pdf 2012-01-27 00:00:00 21601 3 021324 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-324_Entocort.cfm 2001-10-02 00:00:00 21602 3 021330 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-330_Commit.cfm 2004-06-29 00:00:00 21603 3 021334 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S10_Avelox.cfm 2004-05-27 00:00:00 21604 3 021335 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21335_Gleevec.cfm 2001-05-10 00:00:00 21605 3 021335 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335s001_Gleevec.cfm 2003-07-08 00:00:00 21606 3 021335 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm 2004-08-09 00:00:00 21607 3 021336 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm 2007-09-10 00:00:00 21608 3 021337 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21337_Invanz.cfm 2001-11-09 00:00:00 21609 3 021342 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-342_Levothyroxine.cfm 2002-06-19 00:00:00 21610 3 021343 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-343_Eligard.cfm 2002-01-23 00:00:00 21611 3 021346 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21346_RisperdalTOC.cfm 2005-06-16 00:00:00 21612 3 021348 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-348_Zavesca.cfm 2003-12-15 00:00:00 21613 3 021356 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread.cfm 2001-10-26 00:00:00 21614 3 021357 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021357_021358_Multihance.cfm 2005-03-28 00:00:00 21615 3 021358 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021358s000_021357s000_MultiHance.cfm 2005-04-17 00:00:00 21616 3 021359 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021359_rectiv_toc.cfm 2012-02-29 00:00:00 21617 3 021360 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-360_EfavirenzSustiva.cfm 2002-05-15 00:00:00 21618 3 021360 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021360_S014_SUSTIVA.pdf 2007-07-20 00:00:00 21619 3 021365 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S007&021365_S001_LEXAPRO_TABS.pdf 2007-07-06 00:00:00 21620 3 021365 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021323_S003&021365_S004_LEXAPRO_TABS.pdf 2007-07-06 00:00:00 21621 3 021366 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-366_Crestor.cfm 2004-01-29 00:00:00 21622 3 021366 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021366s024.pdf 2012-03-30 00:00:00 21623 3 021367 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021367TOC.cfm 2003-07-16 00:00:00 21624 3 021368 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021368Orig1s020.pdf 2014-01-17 00:00:00 21625 3 021371 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-371_Estrasorb.cfm 2005-01-11 00:00:00 21626 3 021372 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-372_Alox.cfm 2004-01-15 00:00:00 21627 3 021372 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021372s008s010TOC.cfm 2009-12-12 00:00:00 21628 3 021378 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021378s000_CombunoxTOC.cfm 2005-11-30 00:00:00 21629 3 021387 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-387_Pravagard.cfm 2004-01-29 00:00:00 21630 3 021392 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-392_CardizemTOC.cfm 2005-06-27 00:00:00 21631 3 021392 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021392_S002_CARDIZEM_LA_EXENTED_AP.pdf 2007-07-06 00:00:00 21632 3 021394 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021393,021394_AdvilTOC.cfm 2006-09-07 00:00:00 21633 3 021395 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm 2004-05-06 00:00:00 21634 3 021396 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-396_Prempro.cfm 2005-04-15 00:00:00 21635 3 021397 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-397_21-423_21-424_Neurontin.cfm 2004-05-06 00:00:00 21636 3 021399 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021399_iressa.cfm 2003-07-15 00:00:00 21637 3 021400 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-400_Levitra.cfm 2003-10-29 00:00:00 21638 3 021406 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021406s000TOC.cfm 2007-05-09 00:00:00 21639 3 021409 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-409_Singulair.cfm 2004-11-22 00:00:00 21640 3 021409 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf 2007-07-09 00:00:00 21641 3 021409 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021409_S007_SINGULAIR_TABLETS_AP.pdf 2007-07-06 00:00:00 21642 3 021411 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021411_S001_STRATTERA_CAPSULES_AP.pdf 2007-07-06 00:00:00 21643 3 021415 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021415s000_MetvixiaTOC.cfm 2006-03-21 00:00:00 21644 3 021417 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-417_Premarin.cfm 2003-09-25 00:00:00 21645 3 021425 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021425_ultravist.cfm 2003-06-26 00:00:00 21646 3 021426 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021426s000TOC.cfm 2007-06-11 00:00:00 21647 3 021426 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021426Orig1s004.pdf 2012-10-12 00:00:00 21648 3 021426 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021426Orig1s007.pdf 2013-05-02 00:00:00 21649 3 021427 SUPPL 39 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021427Orig1s039.pdf 2012-05-09 00:00:00 21650 3 021428 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021428_S004_PREVACID DELAYED RELEASE CAPS.pdf 2008-07-31 00:00:00 21651 3 021433 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021433s000_FloventHFATOC.cfm 2005-12-06 00:00:00 21652 3 021436 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021436_S001_ABILIFY_TABLETS.pdf 2007-09-24 00:00:00 21653 3 021436 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021436Orig1s002.pdf 2013-05-10 00:00:00 21654 3 021436 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021436Orig1s007.pdf 2013-08-06 00:00:00 21655 3 021436 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021436s018TOC.cfm 2009-08-20 00:00:00 21656 3 021436 SUPPL 38 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021436Orig1s038.pdf 2016-04-20 00:00:00 21657 3 021436 SUPPL 40 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/021436Orig1s040.pdf 2016-07-28 00:00:00 21658 3 021437 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-437s002_Inspra.cfm 2004-09-09 00:00:00 21659 3 021440 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-440_21323s1_Lexapro.cfm 2004-04-12 00:00:00 21660 3 021444 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig1s024,s028,s029,21444Orig1s008,s015.pdf 2013-06-03 00:00:00 21661 3 021444 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020272_s046_risperdal_toc.cfm 2011-12-14 00:00:00 21662 3 021445 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21445_Zetia.cfm 2003-02-03 00:00:00 21663 3 021445 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf 2008-02-19 00:00:00 21664 3 021445 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021445_S001_S003_S004_ZETIA_TABLETS.pdf 2008-02-19 00:00:00 21665 3 021446 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021446_LyricaTOC.cfm 2005-07-18 00:00:00 21666 3 021446 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021446Orig1s028_lyrica_toc.cfm 2012-07-06 00:00:00 21667 3 021447 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-447_Zanaflex.cfm 2004-03-24 00:00:00 21668 3 021449 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-449_Hepsera.cfm 2004-06-07 00:00:00 21669 3 021450 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-450_Zomig.cfm 2005-04-15 00:00:00 21670 3 021453 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021453_s000_ZeritTOC.cfm 2006-06-08 00:00:00 21671 3 021456 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm 2003-04-25 00:00:00 21672 3 021457 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021457s000TOC.cfm 2007-04-30 00:00:00 21673 3 021463 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021463_fortesta_toc.cfm 2011-09-16 00:00:00 21674 3 021468 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-468_Fosrenol.cfm 2005-01-28 00:00:00 21675 3 021468 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s004_fosrenol.pdf 2011-01-04 00:00:00 21676 3 021470 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-470_Finacea.cfm 2004-03-24 00:00:00 21677 3 021471 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021471s000TOC.cfm 2008-07-09 00:00:00 21678 3 021473 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S005_CIPRO.pdf 2007-07-09 00:00:00 21679 3 021473 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S006_CIPRO.pdf 2007-07-09 00:00:00 21680 3 021473 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021473_S007_CIPRO.pdf 2007-07-09 00:00:00 21681 3 021473 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021473_S009_CIPRO.pdf 2007-07-09 00:00:00 21682 3 021475 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021475s000_MethylinTOC.cfm 2006-07-25 00:00:00 21683 3 021478 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021478_S003_Zovirax_APPROVAL_PACKAGE.pdf 2006-10-25 00:00:00 21684 3 021479 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021479_zelapar_toc.cfm 2009-01-15 00:00:00 21685 3 021484 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021484_bravelle.cfm 2003-05-08 00:00:00 21686 3 021485 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-485_Stalevo.cfm 2004-03-24 00:00:00 21687 3 021486 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021486s000TOC.cfm 2007-06-04 00:00:00 21688 3 021488 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021488_eligard.cfm 2003-05-08 00:00:00 21689 3 021489 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021489s000_ProhanceTOC.cfm 2006-07-25 00:00:00 21690 3 021490 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-490_NorethinOvcon.cfm 2005-02-02 00:00:00 21691 3 021492 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-492_Eloxatin.cfm 2002-08-09 00:00:00 21692 3 021492 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021492_s002_EloxatinTOC.cfm 2006-03-24 00:00:00 21693 3 021494 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021494s000_AxidTOC.cfm 2006-09-27 00:00:00 21694 3 021496 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21496_Duocaine.cfm 2003-11-06 00:00:00 21695 3 021498 ORIG 1 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021504s000_LidositeTOC.cfm 2006-10-23 00:00:00 21704 3 021505 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/0221505_s000_Keppra.cfm 2004-11-01 00:00:00 21705 3 021506 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-506_Mycamine.cfm 2005-08-24 00:00:00 21706 3 021511 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-511_Copegus.cfm 2004-08-10 00:00:00 21707 3 021513 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-513_Enablex.cfm 2005-02-08 00:00:00 21708 3 021514 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021514_daytrana_toc.cfm 2008-11-14 00:00:00 21709 3 021515 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm 2007-06-29 00:00:00 21710 3 021516 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021516s000_IstalolTOC.cfm 2006-01-31 00:00:00 21711 3 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3 021585 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021585s000_MucinexTOC.cfm 2005-12-01 00:00:00 21745 3 021586 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021586s000TOC.cfm 2008-08-22 00:00:00 21746 3 021587 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-587_Advil.cfm 2005-04-27 00:00:00 21747 3 021588 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021588_s005_GLEVAC.pdf 2015-05-26 00:00:00 21748 3 021588 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s011_gleevec.pdf 2006-10-19 00:00:00 21749 3 021588 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021588_s017_gleevec.pdf 2006-10-19 00:00:00 21750 3 021589 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021589s000_KemstroTOC.cfm 2006-07-25 00:00:00 21751 3 021590 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021590s000_FazacloTOC.cfm 2005-10-06 00:00:00 21752 3 021592 ORIG 1 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021624Orig1s001.pdf 2013-06-03 00:00:00 21761 3 021625 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21625s000_MVI_AdultTOC.cfm 2006-10-25 00:00:00 21762 3 021626 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-626_Radiogardase.cfm 2003-12-31 00:00:00 21763 3 021632 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021632_021948_EraxisTOC.cfm 2006-04-14 00:00:00 21764 3 021640 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-640_Vitrase.cfm 2004-08-27 00:00:00 21765 3 021641 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021641s000_AzilectTOC.cfm 2006-07-24 00:00:00 21766 3 021646 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021646s000_Influvite_PediatricTOC.cfm 2006-09-07 00:00:00 21767 3 021648 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021648s000TOC.cfm 2007-06-04 00:00:00 21768 3 021654 SUPPL 16 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021674_s000_MenostarTOC.cfm 2006-01-03 00:00:00 21777 3 021681 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm 2005-02-02 00:00:00 21778 3 021687 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-687_Vytorin.cfm 2004-11-22 00:00:00 21779 3 021688 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm 2004-05-10 00:00:00 21780 3 021693 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021693s000TOC.cfm 2007-08-22 00:00:00 21781 3 021695 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021695s000_AntaraTOC.cfm 2006-06-08 00:00:00 21782 3 021698 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021698s000TOC.cfm 2007-06-04 00:00:00 21783 3 021710 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021710s000_EquetroTOC.cfm 2006-07-05 00:00:00 21784 3 021711 ORIG 1 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf 2012-02-15 00:00:00 24590 1 020216 SUPPL 75 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020216s073,s074,s075ltr.pdf 2012-02-15 00:00:00 24591 1 020220 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20220scp018ltr.pdf 2004-03-16 00:00:00 24592 1 020220 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020220s027ltr.pdf 2007-09-06 00:00:00 24593 1 020220 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s033,021425s017ltr.pdf 2010-01-05 00:00:00 24594 1 020220 SUPPL 35 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020220s035,021425s019,022090s002ltr.pdf 2010-01-20 00:00:00 24595 1 020221 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20221slr017ltr.pdf 2003-04-15 00:00:00 24596 1 020221 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020221s020ltr.pdf 2006-04-05 00:00:00 24597 1 020221 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020221s024ltr.pdf 2008-11-13 00:00:00 24598 1 020222 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017563Orig1s023,20222Orig1s005ltr.pdf 2014-05-23 00:00:00 24599 1 020225 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20225slr008ltr.pdf 2004-06-07 00:00:00 24604 1 020231 SUPPL 41 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020231s041ltr.pdf 2005-08-08 00:00:00 24605 1 020231 SUPPL 43 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020231s043LTR.pdf 2006-04-25 00:00:00 24606 1 020231 SUPPL 50 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s050ltr.pdf 2007-03-23 00:00:00 24607 1 020231 SUPPL 52 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020231s052ltr.pdf 2007-11-19 00:00:00 24608 1 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016608s096,018281s044,018927s035,020234s025ltr.pdf 2007-08-17 00:00:00 24616 1 020234 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/016608Orig1s097 018281Orig1s045,018927Orig1s038,020234Orig1s026ltr.pdf 2015-09-01 00:00:00 24617 1 020234 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016608Orig1s099,018281Orig1s047,018927Orig1s040,020234Orig1s030ltr.pdf 2014-09-17 00:00:00 24618 1 020234 SUPPL 32 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018281s048,020234s032ltr.pdf 2009-05-01 00:00:00 24619 1 020234 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s100,s102,018281s049,s050,018927s041,s042,020234s031,s033ltr.pdf 2011-03-07 00:00:00 24620 1 020234 SUPPL 39 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/016608s106,018281s054,018927s047,020234s039ltr.pdf 2011-11-10 00:00:00 24621 1 020235 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20235s11ltr.pdf 1998-09-29 00:00:00 24622 1 020235 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf 2000-10-12 00:00:00 24623 1 020235 SUPPL 36 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,021129s022ltr.pdf 2011-03-07 00:00:00 24624 1 020235 SUPPL 43 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf 2010-10-13 00:00:00 24625 1 020235 SUPPL 54 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 2013-05-07 00:00:00 24626 1 020235 SUPPL 56 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf 2013-05-07 00:00:00 24627 1 020235 SUPPL 61 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20239se1-008ltr.pdf 2002-08-16 00:00:00 24635 1 020239 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf 2004-09-21 00:00:00 24636 1 020239 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20239s016,017ltr.pdf 2004-09-21 00:00:00 24637 1 020241 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s2ltr.pdf 1998-08-24 00:00:00 24638 1 020241 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 2006-09-27 00:00:00 24639 1 020241 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-017,20764se1-011ltr.pdf 2003-07-06 00:00:00 24640 1 020241 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241slr018ltr.pdf 2003-04-18 00:00:00 24641 1 020241 SUPPL 25 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantacefferdose_approv.pdf 2004-07-01 00:00:00 24661 1 020251 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf 2002-01-07 00:00:00 24662 1 020251 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018703s068,019675s035,020251s019ltr.pdf 2009-11-12 00:00:00 24663 1 020254 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020254s018ltr.pdf 2009-02-27 00:00:00 24664 1 020254 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020254s019,s020ltr.pdf 2011-02-28 00:00:00 24665 1 020254 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020254Orig1s028ltr.pdf 2016-05-12 00:00:00 24666 1 020255 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20255slr011,009ltr.pdf 2003-07-28 00:00:00 24667 1 020255 SUPPL 16 0 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24814 1 020357 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20357S20ltr.pdf 2001-04-23 00:00:00 24815 1 020357 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf 2002-01-08 00:00:00 24816 1 020357 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf 2004-03-24 00:00:00 24817 1 020357 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015ltr.pdf 2006-11-06 00:00:00 24818 1 020358 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20358s19ltr.pdf 2001-06-11 00:00:00 24819 1 020358 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf 2002-10-02 00:00:00 24820 1 020358 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358s027ltr.pdf 2002-06-14 00:00:00 24821 1 020358 SUPPL 28 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf 2011-05-19 00:00:00 24829 1 020358 SUPPL 50 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050ltr.pdf 2011-07-28 00:00:00 24830 1 020358 SUPPL 53 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf 2013-12-26 00:00:00 24831 1 020358 SUPPL 55 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s048,020358Orig1s055ltr.pdf 2014-12-17 00:00:00 24832 1 020358 SUPPL 57 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018644Orig1s050,020358Orig1s057ltr.pdf 2016-04-27 00:00:00 24833 1 020363 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf 1998-06-12 00:00:00 24834 1 020363 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20363S19LTR.PDF 2001-03-29 00:00:00 24835 1 020363 SUPPL 26 0 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2005-10-25 00:00:00 24890 1 020387 SUPPL 40 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s040ltr.pdf 2007-01-08 00:00:00 24891 1 020387 SUPPL 41 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020387s041ltr.pdf 2006-09-18 00:00:00 24892 1 020387 SUPPL 45 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020387s045ltr.pdf 2009-06-17 00:00:00 24893 1 020387 SUPPL 50 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 2011-06-17 00:00:00 24894 1 020387 SUPPL 52 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s052ltr.pdf 2011-08-18 00:00:00 24895 1 020387 SUPPL 54 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020386s056,020387s054ltr.pdf 2011-11-21 00:00:00 24896 1 020387 SUPPL 55 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020387s055ltr.pdf 2011-08-31 00:00:00 24897 1 020387 SUPPL 59 0 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1999-12-30 00:00:00 26078 1 020864 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf 2002-04-22 00:00:00 26079 1 020864 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 2011-12-21 00:00:00 26080 1 020864 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 2011-12-21 00:00:00 26081 1 020865 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 2011-12-21 00:00:00 26082 1 020865 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020865s014ltr.pdf 2010-08-16 00:00:00 26083 1 020868 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20868slr006ltr.pdf 2004-03-24 00:00:00 26084 1 020868 SUPPL 9 0 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2005-07-15 00:00:00 26129 1 020895 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020895s023ltr.pdf 2006-10-13 00:00:00 26130 1 020895 SUPPL 39 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020895Orig1s039,s042ltr.pdf 2014-03-11 00:00:00 26131 1 020895 SUPPL 44 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020895Orig1s044ltr.pdf 2015-03-27 00:00:00 26132 1 020896 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20896s10s11ltr.pdf 2001-09-07 00:00:00 26133 1 020896 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020896Orig1s034ltr.pdf 2014-10-21 00:00:00 26134 1 020896 SUPPL 36 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020896Orig1s036ltr.pdf 2015-03-03 00:00:00 26135 1 020897 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20897ltr.pdf 1998-12-16 00:00:00 26136 1 020897 SUPPL 13 0 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2002-05-16 00:00:00 26704 1 021085 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 2003-03-10 00:00:00 26705 1 021085 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21085slr014se1-015slr017,21277slr006se1-007slr009ltr.pdf 2003-03-10 00:00:00 26706 1 021085 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21277slr011,21085slr019ltr.pdf 2003-10-06 00:00:00 26707 1 021085 SUPPL 39 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021085s039, 021277s033ltr.pdf 2008-12-31 00:00:00 26708 1 021085 SUPPL 42 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s042,021277s036ltr.pdf 2009-05-05 00:00:00 26709 1 021085 SUPPL 45 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021085s045,021277s039ltr.pdf 2010-01-25 00:00:00 26710 1 021085 SUPPL 52 0 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2000-08-25 00:00:00 26776 1 021110 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00 26777 1 021110 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00 26778 1 021110 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 2003-01-23 00:00:00 26779 1 021110 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr012,%2021110slr011ltr.pdf 2004-06-14 00:00:00 26780 1 021110 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21110slr013,21083slr014ltr.pdf 2003-03-28 00:00:00 26781 1 021110 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr015,21110slr015ltr.pdf 2003-10-02 00:00:00 26782 1 021110 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21110scf018ltr.pdf 2004-03-02 00:00:00 26783 1 021110 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21083s017,21110s020ltr.pdf 2004-07-21 00:00:00 26784 1 021110 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21083s019,21110s024ltr.pdf 2005-03-14 00:00:00 26785 1 021110 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf 2005-07-08 00:00:00 26786 1 021110 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf 2005-10-14 00:00:00 26787 1 021110 SUPPL 34 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf 2006-06-06 00:00:00 26788 1 021110 SUPPL 38 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s030, 021110s038ltr.pdf 2007-01-25 00:00:00 26789 1 021110 SUPPL 39 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s031,021110s039ltr.pdf 2007-05-09 00:00:00 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1 021567 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s007ltr.pdf 2006-01-30 00:00:00 28127 1 021567 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf 2006-08-14 00:00:00 28128 1 021567 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf 2006-08-14 00:00:00 28129 1 021567 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s012LTR.pdf 2007-03-31 00:00:00 28130 1 021567 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s014ltr.pdf 2008-01-09 00:00:00 28131 1 021567 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s015ltr.pdf 2008-03-28 00:00:00 28132 1 021567 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s017ltr.pdf 2008-10-02 00:00:00 28133 1 021567 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s018ltr.pdf 2008-02-22 00:00:00 28134 1 021567 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021567s019ltr.pdf 2010-01-25 00:00:00 28135 1 021567 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021567s022ltr.pdf 2010-01-28 00:00:00 28136 1 021567 SUPPL 25 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s025ltr.pdf 2011-02-10 00:00:00 28137 1 021567 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s026ltr.pdf 2011-10-19 00:00:00 28138 1 021567 SUPPL 28 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021567s028ltr.pdf 2012-03-16 00:00:00 28139 1 021567 SUPPL 31 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s031ltr.pdf 2013-02-04 00:00:00 28140 1 021567 SUPPL 33 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s032,s033ltr.pdf 2013-08-20 00:00:00 28141 1 021567 SUPPL 35 0 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00:00:00 28163 1 021575 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020560s046,021575s009ltr.pdf 2005-11-08 00:00:00 28164 1 021575 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020560s47s48,021575s10s11,021762s2s3ltr.pdf 2007-01-08 00:00:00 28165 1 021575 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020560s052, 021575s013, 021762s006ltr.pdf 2008-10-09 00:00:00 28166 1 021575 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 2010-03-05 00:00:00 28167 1 021575 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020560s056,021575s017ltr.pdf 2012-02-08 00:00:00 28168 1 021575 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020560s051s055s057,021575s012s016s018ltr.pdf 2010-03-05 00:00:00 28169 1 021575 SUPPL 22 0 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2006-10-23 00:00:00 28192 1 021588 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021588s020ltr.pdf 2007-09-25 00:00:00 28193 1 021588 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s022ltr.pdf 2008-10-01 00:00:00 28194 1 021588 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021588s024ltr.pdf 2008-10-01 00:00:00 28195 1 021588 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s026,021588s028ltr.pdf 2009-06-02 00:00:00 28196 1 021588 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021588s027ltr.pdf 2009-02-13 00:00:00 28197 1 021588 SUPPL 30 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021588s030,s031ltr.pdf 2011-04-06 00:00:00 28198 1 021588 SUPPL 42 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021588Orig1s042ltr.pdf 2015-02-02 00:00:00 28199 1 021589 ORIG 1 0 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2003-05-29 00:00:00 28223 1 021598 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21598scp001,slr005ltr.pdf 2003-10-03 00:00:00 28224 1 021598 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr002ltr.pdf 2004-04-20 00:00:00 28225 1 021598 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21598slr008ltr.pdf 2004-07-01 00:00:00 28226 1 021602 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021602s007ltr.pdf 2005-12-15 00:00:00 28227 1 021602 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021602s008, s009LTR.pdf 2006-06-02 00:00:00 28228 1 021602 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021602s019s020ltr.pdf 2010-01-05 00:00:00 28229 1 021602 SUPPL 23 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021602s023ltr.pdf 2010-12-07 00:00:00 28230 1 021602 SUPPL 27 0 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00:00:00 28734 1 021866 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf 2007-11-19 00:00:00 28735 1 021866 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf 2008-05-14 00:00:00 28736 1 021866 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf 2008-05-14 00:00:00 28737 1 021866 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf 2008-03-07 00:00:00 28738 1 021866 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf 2008-08-19 00:00:00 28739 1 021866 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf 2009-07-24 00:00:00 28740 1 021866 SUPPL 15 0 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2010-10-13 00:00:00 28807 1 021902 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021902s000ltr.pdf 2006-11-06 00:00:00 28808 1 021902 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021902s001ltr.pdf 2007-06-07 00:00:00 28809 1 021906 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s012, 021906s002_LTR.pdf 2007-04-25 00:00:00 28810 1 021906 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021906s003, 21251s013ltr.pdf 2007-01-08 00:00:00 28811 1 021906 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s014, 021906s004ltr.pdf 2007-03-07 00:00:00 28812 1 021906 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s018, 021906s007ltr.pdf 2007-11-19 00:00:00 28813 1 021906 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021906s008, 021251s019ltr.pdf 2007-10-04 00:00:00 28814 1 021906 SUPPL 13 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s025ltr.pdf 2015-04-01 00:00:00 29258 1 022107 SUPPL 26 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022107Orig1s026ltr.pdf 2015-12-23 00:00:00 29259 1 022108 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022108s002ltr.pdf 2011-05-04 00:00:00 29260 1 022108 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf 2011-07-28 00:00:00 29261 1 022108 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf 2011-07-28 00:00:00 29262 1 022108 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022108Orig1s007ltr.pdf 2012-08-17 00:00:00 29263 1 022108 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022108Orig1s011ltr.pdf 2014-07-10 00:00:00 29264 1 022110 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022110s000ltr.pdf 2009-09-16 00:00:00 29265 1 022110 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022110s002ltr_corrected.pdf 2011-07-27 00:00:00 29266 1 022114 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022114s000ltr.pdf 2007-08-17 00:00:00 29267 1 022114 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022114s001ltr.pdf 2009-01-12 00:00:00 29268 1 022115 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022115s001,s005ltr.pdf 2010-04-19 00:00:00 29269 1 022115 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s006ltr.pdf 2011-04-28 00:00:00 29270 1 022115 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 2015-03-25 00:00:00 29271 1 022115 SUPPL 16 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021548s028,022116s012ltr.pdf 2012-05-02 00:00:00 29278 1 022116 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021548Orig1s031,022116Orig1s015ltr.pdf 2013-02-14 00:00:00 29279 1 022116 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022116Orig1s020,021548Orig1s036ltr.pdf 2015-04-01 00:00:00 29280 1 022116 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021548Orig1s037,022116Orig1s021ltr.pdf 2016-03-24 00:00:00 29281 1 022117 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022117s003s004ltr.pdf 2010-09-21 00:00:00 29282 1 022117 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022117s009ltr.pdf 2011-10-13 00:00:00 29283 1 022117 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022117Orig1s012ltr.pdf 2013-03-22 00:00:00 29284 1 022117 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022117Orig1s013ltr.pdf 2012-11-09 00:00:00 29285 1 022117 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf 2014-11-19 00:00:00 29286 1 022117 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022117Orig1s014,s015,s016ltr.pdf 2014-11-19 00:00:00 29287 1 022117 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf 2015-03-13 00:00:00 29288 1 022117 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022117Orig1s017,s018,s019ltr.pdf 2015-03-13 00:00:00 29289 1 022118 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022118s000ltr.pdf 2007-08-14 00:00:00 29290 1 022119 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022119s001ltr.pdf 2011-01-07 00:00:00 29292 1 022122 ORIG 1 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s010ltr.pdf 2013-02-04 00:00:00 29300 1 022128 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s011ltr.pdf 2013-02-19 00:00:00 29301 1 022128 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022128Orig1s015ltr.pdf 2015-04-22 00:00:00 29302 1 022129 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022129s000ltr.pdf 2009-04-16 00:00:00 29303 1 022129 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022129Orig1s005ltr.pdf 2012-07-17 00:00:00 29304 1 022134 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022134s000ltr.pdf 2010-07-30 00:00:00 29305 1 022134 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022134Orig1s001ltr.pdf 2014-12-05 00:00:00 29306 1 022137 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022137s000ltr.pdf 2007-09-25 00:00:00 29307 1 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2008-05-15 00:00:00 29367 1 022185 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022185s003ltr.pdf 2009-03-24 00:00:00 29368 1 022185 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022185Orig1s010ltr.pdf 2012-10-22 00:00:00 29369 1 022185 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022185Orig1s015,s016ltr.pdf 2013-11-08 00:00:00 29370 1 022185 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s018ltr.pdf 2014-09-03 00:00:00 29371 1 022185 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022185Orig1s020ltr.pdf 2014-07-29 00:00:00 29372 1 022186 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022186s000ltr.pdf 2008-08-13 00:00:00 29373 1 022187 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022187s000ltr.pdf 2008-01-23 00:00:00 29374 1 022187 SUPPL 2 0 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2013-03-06 00:00:00 29397 1 022201 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s003ltr.pdf 2013-08-20 00:00:00 29398 1 022202 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022202s000ltr.pdf 2009-06-23 00:00:00 29399 1 022202 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022202s003s,s004ltr.pdf 2011-05-06 00:00:00 29400 1 022203 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022203s000ltr.pdf 2008-10-22 00:00:00 29401 1 022203 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022203s003ltr.pdf 2009-11-24 00:00:00 29402 1 022203 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf 2015-02-24 00:00:00 29403 1 022203 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022203Orig1s010,s011ltr.pdf 2015-02-24 00:00:00 29404 1 022204 SUPPL 4 0 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00:00:00 29420 1 022219 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022219Orig1s003ltr.pdf 2015-03-04 00:00:00 29421 1 022220 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022220s000ltr.pdf 2008-06-20 00:00:00 29422 1 022221 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022221s000ltr.pdf 2008-10-09 00:00:00 29423 1 022222 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022222s000ltr.pdf 2012-03-01 00:00:00 29424 1 022223 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022048s000, 022223s000ltr.pdf 2008-01-09 00:00:00 29425 1 022224 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022224s003ltr.pdf 2010-09-16 00:00:00 29426 1 022224 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s004ltr.pdf 2011-03-16 00:00:00 29427 1 022224 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022224s005,s006ltr.pdf 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2012-08-30 00:00:00 29490 1 022264 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022264s006ltr.pdf 2011-09-28 00:00:00 29491 1 022264 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021999Orig1s029,022264Orig1s010ltr.pdf 2014-05-01 00:00:00 29492 1 022264 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf 2014-11-14 00:00:00 29493 1 022264 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022264Orig1s013,s014ltr.pdf 2014-11-14 00:00:00 29494 1 022266 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022266s000ltr.pdf 2009-07-17 00:00:00 29495 1 022266 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022266s001ltr.pdf 2010-07-08 00:00:00 29496 1 022266 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022266s008ltr.pdf 2012-01-03 00:00:00 29497 1 022266 SUPPL 14 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s027ltr.pdf 2015-08-13 00:00:00 29505 1 022273 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022273S000ltr.pdf 2008-12-29 00:00:00 29506 1 022273 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022273s001ltr.pdf 2009-11-24 00:00:00 29507 1 022275 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022275s000ltr.pdf 2009-05-27 00:00:00 29508 1 022275 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022275s003ltr.pdf 2011-09-28 00:00:00 29509 1 022275 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022275Orig1s007ltr.pdf 2012-11-19 00:00:00 29510 1 022275 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022275Orig1s009ltr.pdf 2013-04-18 00:00:00 29511 1 022275 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022275Orig1s014ltr.pdf 2014-03-05 00:00:00 29512 1 022277 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2010-12-22 00:00:00 29520 1 022281 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s003ltr.pdf 2010-12-22 00:00:00 29521 1 022281 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022281Orig1s008ltr.pdf 2015-06-11 00:00:00 29522 1 022282 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022282s000ltr.pdf 2011-12-07 00:00:00 29523 1 022285 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021035Orig1s089,021505Orig1s030,021872Orig1s012,s013,022285Orig1s015ltr.pdf 2013-07-26 00:00:00 29524 1 022285 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021035Orig1s093,021505Orig1s033,021872Orig1s017,022285Orig1s017ltr.pdf 2015-03-12 00:00:00 29525 1 022285 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022285Orig1s018ltr.pdf 2014-08-04 00:00:00 29526 1 022285 SUPPL 20 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022287s012ltr.pdf 2011-05-25 00:00:00 29534 1 022287 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s014ltr.pdf 2012-10-02 00:00:00 29535 1 022287 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022287Orig1s015ltr.pdf 2012-05-09 00:00:00 29536 1 022287 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022287Orig1s017ltr.pdf 2013-08-22 00:00:00 29537 1 022287 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022287Orig1s019ltr.pdf 2014-12-23 00:00:00 29538 1 022287 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s020ltr.pdf 2016-02-04 00:00:00 29539 1 022287 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022287Orig1s021,022287Orig1s022,022287Orig1s023,208056Orig1s001ltr.pdf 2016-07-12 00:00:00 29540 1 022287 SUPPL 22 0 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http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 2013-07-12 00:00:00 29555 1 022304 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 2013-07-12 00:00:00 29556 1 022304 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 2013-07-12 00:00:00 29557 1 022304 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf 2013-11-06 00:00:00 29558 1 022305 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022305s000ltr.pdf 2011-09-16 00:00:00 29559 1 022307 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022307s000_ltr.pdf 2009-07-13 00:00:00 29560 1 022307 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022307s001ltr.pdf 2010-04-22 00:00:00 29561 1 022307 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307s006ltr.pdf 2012-03-27 00:00:00 29562 1 022307 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022307Orig1s007ltr.pdf 2012-12-04 00:00:00 29563 1 022307 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022307Orig1s008ltr.pdf 2013-10-17 00:00:00 29564 1 022307 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022307Orig1s012ltr.pdf 2015-07-10 00:00:00 29565 1 022307 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s013ltr.pdf 2016-01-15 00:00:00 29566 1 022307 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022307Orig1s014ltr.pdf 2016-07-13 00:00:00 29567 1 022308 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022308Orig1s003ltr.pdf 2012-09-24 00:00:00 29568 1 022309 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022309Orig1s001ltr.pdf 2012-09-10 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2011-06-16 00:00:00 38212 2 022088 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 2011-06-16 00:00:00 38213 2 022088 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 2011-06-16 00:00:00 38214 2 022088 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022088s014lbl.pdf 2012-06-06 00:00:00 38215 2 022088 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s016lbl.pdf 2014-04-08 00:00:00 38216 2 022090 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022090lbl.pdf 2008-07-09 00:00:00 38217 2 022090 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022090s004lbl.pdf 2010-12-20 00:00:00 38218 2 022090 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022090s005lbl.pdf 2011-11-21 00:00:00 38219 2 022090 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022090s008lbl.pdf 2013-10-18 00:00:00 38220 2 022090 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022090s011lbl.pdf 2015-04-01 00:00:00 38221 2 022100 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022100lbl.pdf 2007-10-04 00:00:00 38222 2 022100 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022100s002lbl.pdf 2009-05-13 00:00:00 38223 2 022100 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s010s012lbl.pdf 2011-05-23 00:00:00 38224 2 022100 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s013lbl.pdf 2011-11-14 00:00:00 38225 2 022100 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022100s014lbl.pdf 2011-10-31 00:00:00 38226 2 022100 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s016lbl.pdf 2012-01-23 00:00:00 38227 2 022100 SUPPL 20 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022100s020lbl.pdf 2012-12-13 00:00:00 38228 2 022100 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2 040335 SUPPL 8 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf 2012-08-30 00:00:00 38886 2 040347 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40347_Leucovorin%20Calcium_Prntlbl.pdf 2004-06-08 00:00:00 38887 2 040347 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040347s010lbl.pdf 2012-08-30 00:00:00 38888 2 040361 SUPPL 17 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040361Orig1s017lbl.pdf 2014-08-06 00:00:00 38889 2 040372 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/40372_Promethazine%20Hydrochloride_Prntlbl.pdf 2004-06-14 00:00:00 38890 2 040386 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40386_Triamcinolone%20Acetonide_Prntlbl.pdf 2003-12-23 00:00:00 38891 2 040415 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf 2007-01-16 00:00:00 38892 2 040418 ORIG 1 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20757-s016_avapro.pdf 2004-05-27 00:00:00 41656 3 020757 SUPPL 18 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s018_Avapro_P1.pdf 2005-04-27 00:00:00 41657 3 020757 SUPPL 21 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s021_Avapro.cfm 2004-05-27 00:00:00 41658 3 020757 SUPPL 22 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s022_Avapro.PDF 2005-04-27 00:00:00 41659 3 020757 SUPPL 24 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P1.PDF 2005-05-05 00:00:00 41660 3 020757 SUPPL 27 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s027_Avapro.PDF 2005-07-29 00:00:00 41661 3 020757 SUPPL 28 Review Part 2 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s028_Avapro_P2.PDF 2005-07-29 00:00:00 41662 3 020757 SUPPL 31 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s031_Avapro.PDF 2005-05-03 00:00:00 41663 3 020757 SUPPL 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00:00:00 41679 3 020766 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020766a.cfm 1999-08-13 00:00:00 41680 3 020766 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020766_S009_XENICAL_CAPS_AP.pdf 2007-07-06 00:00:00 41681 3 020766 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020766_S019_XENICAL_CAPS_AP.pdf 2007-07-06 00:00:00 41682 3 020767 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20210-S030_Propulsid.pdf 2000-03-06 00:00:00 41683 3 020767 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20767-S011_Propulsid.pdf 2000-03-06 00:00:00 41684 3 020769 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020769_locoid_toc.cfm 2003-08-07 00:00:00 41685 3 020771 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20771_Detrol.cfm 1998-03-25 00:00:00 41686 3 020771 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020771_s009_DETROL.pdf 2008-08-04 00:00:00 41687 3 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm 2000-08-30 00:00:00 41696 3 020780 SUPPL 13 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm 2008-07-31 00:00:00 41697 3 020780 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020780_S014_CIPRO.pdf 2007-11-19 00:00:00 41698 3 020781 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20781_Zofran.pdf 1999-01-27 00:00:00 41699 3 020784 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020784s000TOC.cfm 2007-07-03 00:00:00 41700 3 020785 SUPPL 14 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf 2001-09-05 00:00:00 41701 3 020786 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020786_allegra-d_toc.cfm 2010-05-25 00:00:00 41702 3 020786 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s001_ALLEGRA TABS.pdf 2008-08-08 00:00:00 41703 3 020786 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s003_ALLEGRA TABS.pdf 2008-08-08 00:00:00 41704 3 020786 SUPPL 4 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s004_ALLEGRA CAPSULES.pdf 2008-08-04 00:00:00 41705 3 020786 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s005_ALLEGRA D.pdf 2008-08-08 00:00:00 41706 3 020786 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s006_ALLEGRA CAPSULES.pdf 2008-08-04 00:00:00 41707 3 020786 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020786_s009_ALLEGRA D.pdf 2008-08-04 00:00:00 41708 3 020789 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020789_Zonegran.cfm 2000-03-27 00:00:00 41709 3 020800 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-800_Twinject.cfm 2005-04-08 00:00:00 41710 3 020801 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20801.cfm 1998-09-24 00:00:00 41711 3 020802 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020802_s000_ExcedrinTOC.cfm 2005-07-13 00:00:00 41712 3 020802 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-802s002_Excedrin.cfm 1999-10-07 00:00:00 41713 3 020803 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020803_alrex_toc.cfm 2003-08-07 00:00:00 41714 3 020805 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20805.cfm 1998-02-10 00:00:00 41715 3 020808 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20808-S1_Visipaque.pdf 2004-06-30 00:00:00 41716 3 020809 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20809A_Diclofenac.cfm 1998-05-04 00:00:00 41717 3 020812 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020812Orig1s007.pdf 2013-05-10 00:00:00 41718 3 020815 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020815_evista_toc.cfm 2009-12-03 00:00:00 41719 3 020815 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20815S3_Evista.cfm 1999-09-30 00:00:00 41720 3 020818 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020818_diovan_toc.cfm 2003-08-08 00:00:00 41721 3 020818 SUPPL 16 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-818s016_Diovan.cfm 2003-07-08 00:00:00 41722 3 020822 SUPPL 40 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020822Orig1s038s040_021046Orig1s016s017Rev.pdf 2011-10-11 00:00:00 41723 3 020825 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-825_Geodan.cfm 2001-02-05 00:00:00 41724 3 020827 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20827_Monistat3.cfm 1998-03-30 00:00:00 41725 3 020828 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020828_fortovase_toc.cfm 2010-03-04 00:00:00 41726 3 020828 SUPPL 19 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020828_S019_FORTOVASE.pdf 2007-07-27 00:00:00 41727 3 020828 SUPPL 20 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020835_S014_ACTONEL TABLETS.pdf 2007-07-27 00:00:00 41743 3 020837 SUPPL 10 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020837_S010_Xopenex_APPROVAL PACKAGE.pdf 2006-10-26 00:00:00 41744 3 020838 SUPPL 15 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20838s015_Atacand.cfm 2004-05-27 00:00:00 41745 3 020839 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020-839_S-001.PDF 2005-08-04 00:00:00 41746 3 020839 SUPPL 3 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020-839_S-003.PDF 2005-08-04 00:00:00 41747 3 020839 SUPPL 6 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-006.PDF 2005-08-04 00:00:00 41748 3 020839 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-007.PDF 2005-08-04 00:00:00 41749 3 020839 SUPPL 9 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020-839_S-009.PDF 2005-08-04 00:00:00 41750 3 020839 SUPPL 10 0 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20844S4_Topamax.cfm 2000-07-03 00:00:00 41759 3 020847 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20847.cfm 1998-08-04 00:00:00 41760 3 020850 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20850_Micardis.cfm 2001-08-06 00:00:00 41761 3 020857 SUPPL 11 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020857_S011_Epivir.pdf 2007-09-24 00:00:00 41762 3 020860 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20860.cfm 1999-01-21 00:00:00 41763 3 020864 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20864-20865.cfm 1999-04-08 00:00:00 41764 3 020864 SUPPL 2 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf 2004-04-15 00:00:00 41765 3 020864 SUPPL 5 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-005.pdf 2004-04-21 00:00:00 41766 3 020864 SUPPL 7 0 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-007.pdf 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2013-11-01 00:00:00 44568 14 125511 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=343 2015-01-28 00:00:00 44569 14 200197 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 2015-07-02 00:00:00 44571 14 200792 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2015-06-30 00:00:00 44572 14 200824 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2015-06-30 00:00:00 44573 14 201066 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 2015-07-02 00:00:00 44574 14 201655 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2012-01-05 00:00:00 44575 14 201760 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 2016-02-03 00:00:00 44576 14 201824 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 2015-09-18 00:00:00 44577 14 202099 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24 2015-07-02 00:00:00 44578 14 202121 ORIG 1 Labeling Review http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202121Orig1s000LBL.pdf 2013-06-04 00:00:00 44579 14 202121 SUPPL 1 Bioequivalencew Review http://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/202121Orig1s000BioeqR.pdf 2012-10-15 00:00:00 44580 14 202144 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2015-06-30 00:00:00 44583 14 202718 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2015-01-26 00:00:00 44584 14 202799 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=40 2012-03-28 00:00:00 44585 14 202873 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 2015-11-30 00:00:00 44586 14 203039 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=351 2015-11-30 00:00:00 44587 14 203136 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 2015-07-02 00:00:00 44588 14 203326 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 2015-07-02 00:00:00 44589 14 203506 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2015-06-30 00:00:00 44590 14 203858 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=25 2012-12-28 00:00:00 44591 14 204242 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 2013-07-23 00:00:00 44592 14 204278 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2015-06-30 00:00:00 44593 14 204431 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 2016-02-03 00:00:00 44594 14 204819 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=149 2013-10-15 00:00:00 44595 14 204824 ORIG 1 Orig2 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s000TOC.cfm 2014-02-03 00:00:00 44596 14 205629 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2016-07-22 00:00:00 44597 14 205637 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 2015-01-08 00:00:00 44598 14 205777 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 2015-06-30 00:00:00 44599 14 205858 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=321 2014-08-01 00:00:00 44600 14 206321 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=342 2014-12-31 00:00:00 44601 14 206544 ORIG 1 FDA has determined that this product has abuse-deterrent properties http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm 2015-11-04 00:00:00 44602 14 206545 ORIG 1 REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=321 2014-08-01 00:00:00 44603 14 208090 ORIG 1 FDA has determined that this product has abuse-deterrent properties http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm440121.htm 2015-11-06 00:00:00 44604 15 020449 SUPPL 36 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020449s036PI.pdf 2006-06-08 00:00:00 44606 15 020950 SUPPL 12 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020950s012PI.pdf 2006-06-06 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DD prea.pdf 1900-01-01 00:00:00 51104 61 125553 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz clinpharm addendum prea.pdf 1900-01-01 00:00:00 51105 57 125553 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125553 filgrastim-sndz clinical TL prea.pdf 1900-01-01 00:00:00 51106 20 206307 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206307 finafloxacin clinical bpca.pdf 1900-01-01 00:00:00 51107 18 206307 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206307 finafloxacin ClinPharm bpca.pdf 1900-01-01 00:00:00 51108 17 206307 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/206307 finafloxacin Statistical bpca.pdf 1900-01-01 00:00:00 51110 18 205625 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205625 fluticasone clinpharm prea.pdf 1900-01-01 00:00:00 51111 17 205625 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205625 fluticasone statistical prea.pdf 1900-01-01 00:00:00 51112 20 205625 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205625 fluticasone clinical prea.pdf 1900-01-01 00:00:00 51113 20 021152 SUPPL 4 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21152 fluticasone clinical prea.pdf 1900-01-01 00:00:00 51115 18 021152 SUPPL 4 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21152_cutivate_clinpharm_prea.pdf 1900-01-01 00:00:00 51116 17 021152 SUPPL 4 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21152_cutivate_statistical_prea.pdf 1900-01-01 00:00:00 51119 20 021254 SUPPL 9 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_clinical_prea.pdf 1900-01-01 00:00:00 51120 18 021254 SUPPL 9 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_clinpharm_prea.pdf 1900-01-01 00:00:00 51121 17 021254 SUPPL 9 0 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1900-01-01 00:00:00 51148 18 022090 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022090 gadoxetate clinpharm prea.pdf 1900-01-01 00:00:00 51150 23 020363 SUPPL 36 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Original_WR.pdf 2009-09-21 00:00:00 51151 20 125289 SUPPL 133 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab clinical prea.pdf 1900-01-01 00:00:00 51152 18 125289 SUPPL 133 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab clinpharm prea.pdf 1900-01-01 00:00:00 51153 57 125289 SUPPL 133 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab CDTL clinical prea.pdf 1900-01-01 00:00:00 51154 17 125289 SUPPL 133 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125289s133 golimumab statistical prea.pdf 1900-01-01 00:00:00 51155 23 020983 SUPPL 13 0 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SUPPL 10 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 guanfacine clinpharm both (1).pdf 1900-01-01 00:00:00 51167 17 022037 SUPPL 10 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22037 guanfacine statistical both.pdf 1900-01-01 00:00:00 51168 18 022348 SUPPL 5 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348 ibuprofen clinpharm prea.pdf 1900-01-01 00:00:00 51169 20 022348 SUPPL 5 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348 ibuprofen clinical prea.pdf 1900-01-01 00:00:00 51170 60 022348 SUPPL 5 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348_ibuprofen_DD clinical_PREA.pdf 1900-01-01 00:00:00 51171 17 022348 SUPPL 5 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22348 ibuprofen statistical prea.pdf 1900-01-01 00:00:00 51172 17 125544 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/125544 StatReview.pdf 1900-01-01 00:00:00 51173 20 125544 ORIG 1 0 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methylphenidate clinpharm resubmission prea.pdf 1900-01-01 00:00:00 51371 17 205489 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/148_205489 methylphenidate statistical prea.pdf 1900-01-01 00:00:00 51372 17 205489 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/147_205489 methylphenidate stat resubmission prea.pdf 1900-01-01 00:00:00 51373 20 021506 SUPPL 15 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021506s015 micafungin Mycamine clinical bpca.pdf 1900-01-01 00:00:00 51374 18 021506 SUPPL 15 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021506s015 micafungin Mycamine clinpharm bpca.pdf 1900-01-01 00:00:00 51375 17 021506 SUPPL 15 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021506s015 micafungin Mycamine statistical bpca.pdf 1900-01-01 00:00:00 51376 2 202106 SUPPL 3 0 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202106s003lbl.pdf 2018-01-22 00:00:00 51377 20 022063 ORIG 1 0 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1900-01-01 00:00:00 51527 20 208147 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208147 amphetamine clinical prea.pdf 1900-01-01 00:00:00 51528 18 208147 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208147 amphetamine clinpharm prea.pdf 1900-01-01 00:00:00 51529 17 208147 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208147 amphetamine statistical prea.pdf 1900-01-01 00:00:00 51530 20 021549 SUPPL 25 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant clinical prea.pdf 1900-01-01 00:00:00 51531 20 202810 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202810 oxcarbazepine clinical prea.pdf 1900-01-01 00:00:00 51532 18 202810 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202810 oxcarbazepine clinpharm prea.pdf 1900-01-01 00:00:00 51533 17 202810 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202810 oxcarbazepine statistical prea.pdf 1900-01-01 00:00:00 51534 20 022272 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22272 oxycodone clinical bpca.pdf 1900-01-01 00:00:00 51535 18 022272 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22272 oxycodone clinpharm bpca.pdf 1900-01-01 00:00:00 51536 17 022272 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22272 oxycodone statistical bpca.pdf 1900-01-01 00:00:00 51537 20 021372 SUPPL 19 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron clinical bpca.pdf 1900-01-01 00:00:00 51538 20 021372 SUPPL 18 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron clinical 18 bpca.pdf 1900-01-01 00:00:00 51539 18 021372 SUPPL 19 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron clinpharm bpca.pdf 1900-01-01 00:00:00 51540 17 021372 SUPPL 19 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021372 palonsetron statistical prea.pdf 1900-01-01 00:00:00 51541 20 022003 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/8_22003 posaconazole clinical prea.pdf 1900-01-01 00:00:00 51542 18 022003 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/7_22003 posaconazole clinpharm prea.pdf 1900-01-01 00:00:00 51543 20 103964 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/21511 ribavirin clinical prea-Dawn.pdf 1900-01-01 00:00:00 51544 18 103964 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/196_103964S5270 peginterferon clinpharm prea.pdf 1900-01-01 00:00:00 51545 17 103964 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/197_103964S5270 peginterferon statistical prea.pdf 1900-01-01 00:00:00 51546 20 206426 SUPPL 4 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/188_206426S4 peramivir CDTL statistical prea.pdf 1900-01-01 00:00:00 51547 18 206426 SUPPL 4 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/189_206426S4 peramivir clinpharm prea.pdf 1900-01-01 00:00:00 51549 20 021606 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/28_21606 paricalcitol clinical prea.pdf 1900-01-01 00:00:00 51550 57 021606 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/27_21606 paricalcitol CDTL clinical prea.pdf 1900-01-01 00:00:00 51551 18 021606 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/29_21606 paricalcitol clinpharm prea.pdf 1900-01-01 00:00:00 51552 17 021606 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/30_21606 paricalcitol statistical prea.pdf 1900-01-01 00:00:00 51553 57 205388 SUPPL 6 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/213_205388S6 phenylephrine and ketorolac CDTL clinical bpca.pdf 1900-01-01 00:00:00 51554 20 205388 SUPPL 6 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/214_205388S6 phenylephrine and ketorolac clinical bpca.pdf 1900-01-01 00:00:00 51555 17 205388 SUPPL 6 0 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0 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022382s018lbl.pdf#page=20 2018-01-24 00:00:00 51564 20 203510 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203510 phenylephrine clinical prea.pdf 1900-01-01 00:00:00 51565 18 203510 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203510 phenylephrine clinpharm prea.pdf 1900-01-01 00:00:00 51566 17 203510 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203510 phenylephrine statistical prea.pdf 1900-01-01 00:00:00 51567 20 020427 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_CLINICAL_BPCA.pdf 1900-01-01 00:00:00 51568 18 020427 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_CLINPHARM_BPCA.pdf 1900-01-01 00:00:00 51569 17 020427 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020427s011,s012_VIGABATRIN_STATISTICAL_BPCA.pdf 1900-01-01 00:00:00 51570 20 021936 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/88_21936 tiotropium clinical prea.pdf 1900-01-01 00:00:00 51571 18 021936 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/89_21936 tiotropium clinpharm prea.pdf 1900-01-01 00:00:00 51572 17 021936 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/90_21936 tiotropium statistical prea.pdf 1900-01-01 00:00:00 51573 18 201820 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201820 tobramycin clinpharm prea.pdf 1900-01-01 00:00:00 51574 20 201820 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201820 tobramycin clinical prea.pdf 1900-01-01 00:00:00 51575 17 201820 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/201820 tobramycin statistical prea.pdf 1900-01-01 00:00:00 51576 20 208032 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/208032 tetracaine and oxymetazoline clinical prea.pdf 1900-01-01 00:00:00 51577 18 208032 ORIG 1 0 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prea.pdf 1900-01-01 00:00:00 51584 17 205053 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205053Orig1s000_posaconazole Noxafil_Statistical prea.pdf 1900-01-01 00:00:00 51585 18 021549 SUPPL 25 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant clinpharm prea.pdf 1900-01-01 00:00:00 51586 20 205053 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205053Orig1s000_ posaconazole Noxafil_Clinical prea.pdf 1900-01-01 00:00:00 51587 62 021549 SUPPL 25 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant clinpharm addendum prea.pdf 1900-01-01 00:00:00 51588 18 205053 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/205053Orig1s000_posaconazole Noxafil_Clinpharm prea.pdf 1900-01-01 00:00:00 51589 17 021549 SUPPL 25 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021549Orig1s025 aprepitant statisical prea.pdf 1900-01-01 00:00:00 51590 20 207865 ORIG 1 0 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ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203684 sulfur hexafluoride statistical prea.pdf 1900-01-01 00:00:00 51599 20 021446 SUPPL 32 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/56_21446 22488 pregabalin clinical prea.pdf 1900-01-01 00:00:00 51600 18 021446 SUPPL 32 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/57_21446 22488 pregabalin clinpharm prea.pdf 1900-01-01 00:00:00 51601 17 021446 SUPPL 32 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/58_21446 22488 pregabalin statistical prea.pdf 1900-01-01 00:00:00 51602 62 207865 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207865 aprepitant clinpharm addendum prea.pdf 1900-01-01 00:00:00 51603 17 207865 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207865 aprepitant statistical prea.pdf 1900-01-01 00:00:00 51604 17 021436 SUPPL 36 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021436 aripiprazole statistical prea.pdf 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ciprofloxacin and fluocinolone acetonide statistical prea.pdf 1900-01-01 00:00:00 52573 20 207986 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin clinical prea.pdf 1900-01-01 00:00:00 52574 18 207986 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin clinpharm prea.pdf 1900-01-01 00:00:00 52575 17 207986 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin statistical_prea.pdf 1900-01-01 00:00:00 52576 61 207986 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/207986 ciprofloxacin statistical addendum prea.pdf 1900-01-01 00:00:00 52578 57 207695 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/49_207695 crisaborole CDTL clinical prea.pdf 1900-01-01 00:00:00 52579 20 207695 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50_207695 crisaborole clinical prea-EMV.pdf 1900-01-01 00:00:00 52580 18 207695 ORIG 1 0 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statistical bpca.pdf 1900-01-01 00:00:00 52614 20 204790 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790_dolutegravir_Tivicay_Clinical Rev_PREA.pdf 1900-01-01 00:00:00 52615 20 204790 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790 dolutegravir clinical prea.pdf 1900-01-01 00:00:00 52616 17 204790 ORIG 1 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790_dolutegravir_Tivicay_Stat Rev_PREA.pdf 1900-01-01 00:00:00 52618 57 204790 SUPPL 8 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790 dolutegravir clinical CDTL prea.pdf 1900-01-01 00:00:00 52619 18 204790 SUPPL 8 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/204790 dolutegravir clinpharm prea.pdf 1900-01-01 00:00:00 52621 2 200795 SUPPL 8 0 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200795s008lbl.pdf 2018-02-14 00:00:00 52622 18 050795 SUPPL 10 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050795s010 doxycyclene clinpharm prea.pdf 1900-01-01 00:00:00 52623 17 050795 SUPPL 10 0 https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/050795s010 doxycycline statistical prea.pdf 1900-01-01 00:00:00 52624 2 208470 SUPPL 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208470s001lbl.pdf 2018-02-14 00:00:00 52625 2 125554 SUPPL 56 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s056lbl.pdf 2018-02-14 00:00:00 52626 2 021187 SUPPL 31 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021187s031lbl.pdf 2018-02-14 00:00:00 52627 2 012462 SUPPL 48 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012462s048lbl.pdf 2018-02-14 00:00:00 52628 2 017697 SUPPL 31 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s031lbl.pdf 2018-02-14 00:00:00 52629 2 210951 ORIG 1 0 http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210951s000lbl.pdf 2018-02-14 00:00:00 52630 1 202155 SUPPL 18 0 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