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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S033_DILANTIN_AP.pdf 2007-07-06 00:00:00 AP 0 17091 010151 032 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S032_DILANTIN_AP.pdf 2007-07-06 00:00:00 AP 0 17092 010151 030 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S030_DILANTIN_AP.pdf 2007-07-06 00:00:00 AP 0 17093 010151 029 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/010151_S029_DILANTIN_AP.pdf 2007-07-06 00:00:00 AP 0 17094 013263 075 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S075_VALIUM_AP.pdf 2007-07-06 00:00:00 AP 0 17095 013263 081 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/016087_S081_VALIUM_AP.pdf 2007-07-06 00:00:00 AP 0 17096 020287 017 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020287_S017_FRAGMIN_AP.pdf 2007-07-06 00:00:00 AP 0 17097 020287 015 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020287_S015_FRAGMIN_AP.pdf 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/011213_S024_TRILAFON_AP.pdf 2007-07-06 00:00:00 AP 0 17108 010775 031 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/010775_S031_TRILAFON_AP.pdf 2007-07-06 00:00:00 AP 0 17109 020152 006 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020152_S006_SERZONE_AP.pdf 2007-07-06 00:00:00 AP 0 17110 018281 039 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018281_S039_TEGRETOL_AP.PDF 2007-07-06 00:00:00 AP 0 17111 018281 031 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/018927_S031_TEGRETOL_AP.PDF 2007-07-06 00:00:00 AP 0 17112 040503 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/040503_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17113 075350 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075350_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17114 075360 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/075360_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 1 17115 021392 002 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021392_S002_CARDIZEM_LA_EXENTED_AP.pdf 2007-07-06 00:00:00 AP 0 17116 065162 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065162_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17117 017531 010 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017531_S010_TIGAN_CAPSULE_AP.pdf 2007-07-06 00:00:00 AP 0 17118 018612 034 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018612_S034_NICORETTE_GUM_AP.pdf 2007-07-06 00:00:00 AP 0 17119 075006 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075006_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17120 065184 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065184_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17121 065112 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065112_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17122 016126 017 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S017_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17123 016126 020 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S020_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17124 016126 023 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S023_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17125 016126 024 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/016126_S024_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17126 016126 025 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/016126_S025_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17127 016126 027 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/016126_S027_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17128 016126 028 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016126_S028_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17129 016126 029 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/016126_S029_PRIMATENE MIST.pdf 2007-07-06 00:00:00 AP 0 17130 075988 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075988_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17131 040454 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040454_S000_APPROVAL_PACKAGE.pdf 2007-07-06 00:00:00 AP 0 17132 019386 022 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019386_S022_Brevibloc.pdf 2007-07-06 00:00:00 AP 0 17133 020668 001 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020668_S001_Lexxel Tablets.pdf 2007-07-06 00:00:00 AP 0 17134 020668 002 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/020668_S002_Lexxel Tablets.pdf 2007-07-06 00:00:00 AP 0 17135 017105 062 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S062_TRANXENE_AP.pdf 2007-07-09 00:00:00 AP 0 17136 017105 059 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017105_S059_TRANXENE_AP.pdf 2007-07-09 00:00:00 AP 0 17137 019908 002 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S002_AMBIEN_AP.pdf 2007-07-09 00:00:00 AP 0 17138 021183 001 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021183_S001_VIDEX_AP.pdf 2007-07-09 00:00:00 AP 0 17139 013263 086 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S086_VALIUM_AP.pdf 2007-07-09 00:00:00 AP 0 17140 018248 026 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018248_S026_OXYTOCIN_AP.pdf 2007-07-09 00:00:00 AP 0 17141 018248 027 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018248_S027_OXYTOCIN_AP.pdf 2007-07-09 00:00:00 AP 0 17142 020762 014 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020762_S014_NASONEX_AP.pdf 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075440_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17151 073479 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/073479_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17152 020164 058 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S058_LOVENOX INJECTION_AP.pdf 2007-07-09 00:00:00 AP 0 17153 020164 057 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020164_S057_LOVENOX INJECION_AP.pdf 2007-07-09 00:00:00 AP 0 17155 018938 017 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/018938_S017_DDAVP_AP.pdf 2007-07-09 00:00:00 AP 0 17156 020031 031 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020031_S031_PAXIL_AP.pdf 2007-07-09 00:00:00 AP 0 17157 020031 030 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S030_PAXIL_AP.pdf 2007-07-09 00:00:00 AP 0 17158 020831 002 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020831_S002_FORADIL_AP.pdf 2007-07-09 00:00:00 AP 0 17159 021316 001 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_S001_ALTOCOR_AP.pdf 2007-07-09 00:00:00 AP 0 17160 017530 018 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/017530_S018_TIGAN_AP.pdf 2007-07-09 00:00:00 AP 0 17162 020031 028 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S028_PAXIL_AP.pdf 2007-07-09 00:00:00 AP 0 17163 020031 027 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S027_PAXIL_AP.pdf 2007-07-09 00:00:00 AP 0 17164 020031 025 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020031_S025_PAXIL_AP.pdf 2007-07-09 00:00:00 AP 0 17165 021205 014 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S014_TRIZIVIR_AP.pdf 2007-07-09 00:00:00 AP 0 17166 021205 012 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021205_S012_TRIZIVIR_AP.pdf 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020397_S004_ZANAFLEX TABLETS_AP.pdf 2007-07-09 00:00:00 AP 0 17175 070704 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/070704_ORIGINAL APPROVAL_PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17176 020263 028 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020263_S028_Lupron Depot Ped_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17177 020263 012 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020263_S012_Lupron Depot_APPROVAL_PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17178 020263 006 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S006_Lupron Depot_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17179 020263 003 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S003_Lupron Depot_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17181 020563 009 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020563_S009_Humalog_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_S003_Lupron Depot_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17189 019010 031 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019010_S031_Lupron Injection_APPROVAL_PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17190 019010 024 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S024_Lupron Injection_APPROVAL_PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17191 019010 023 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S023_Lupron Injection_APPROVAL_PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17192 019010 006 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019010_S006_Lupron Injection_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17193 020517 019 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S019_Lupron Depot_APPROVAL PACKAGE.pdf 2007-07-09 00:00:00 AP 0 17194 020517 018 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S018_Lupron 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http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s0000TOC.cfm 2010-08-18 00:00:00 AP 0 26243 125320 0000 Summary Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000SumR.pdf 2010-08-18 00:00:00 AP 0 26244 021457 021 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021457s021lbl.pdf 2010-08-19 00:00:00 AP 0 26245 020839 048 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s048lbl.pdf 2010-08-19 00:00:00 AP 0 26246 020864 013 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020864s013lbl.pdf 2010-08-19 00:00:00 AP 0 26247 020865 014 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf 2010-08-19 00:00:00 AP 0 26249 020725 007 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020725s007lbl.pdf 2010-08-19 00:00:00 AP 0 26250 020132 013 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 2010-08-19 00:00:00 AP 0 26251 020132 020 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 2010-08-19 00:00:00 AP 0 26252 020132 021 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 2010-08-19 00:00:00 AP 0 26253 020132 022 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020132s013s020s021s022lbl.pdf 2010-08-19 00:00:00 AP 0 26254 020768 017 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020768s017lbl.pdf 2010-08-19 00:00:00 AP 0 26255 021231 009 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf 2010-08-19 00:00:00 AP 0 26256 020763 006 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020763s006lbl.pdf 2010-08-19 00:00:00 AP 0 26257 050733 029 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050733s029lbl.pdf 2010-08-19 00:00:00 AP 0 26258 050784 017 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf 2010-08-19 00:00:00 AP 0 26259 050711 030 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf 2010-08-19 00:00:00 AP 0 26260 050710 032 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050710s032,050711s030,050784s017lbl.pdf 2010-08-19 00:00:00 AP 0 26261 050730 025 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf 2010-08-19 00:00:00 AP 0 26262 050693 015 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050693s015,050730s025lbl.pdf 2010-08-19 00:00:00 AP 0 26263 021409 031 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf 2010-08-19 00:00:00 AP 0 26264 020830 056 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf 2010-08-19 00:00:00 AP 0 26265 020829 055 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf 2010-08-19 00:00:00 AP 0 26266 021457 021 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021457s021ltr.pdf 2010-08-20 00:00:00 AP 0 26267 018714 012 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018714s012ltr.pdf 2010-08-20 00:00:00 AP 0 26268 021870 004 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021870s004ltr.pdf 2010-08-20 00:00:00 AP 0 26269 021773 026 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s026ltr.pdf 2010-08-20 00:00:00 AP 0 26270 018814 032 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018814s032ltr.pdf 2010-08-20 00:00:00 AP 0 26271 022421 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000TOC.cfm 2010-08-20 00:00:00 AP 0 26272 022421 000 Summary Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022421s000SumR.pdf 2010-08-20 00:00:00 AP 0 26273 021870 004 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021870s004lbl.pdf 2010-08-20 00:00:00 AP 0 26274 020868 008 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020868s008lbl.pdf 2010-08-20 00:00:00 AP 0 26275 020334 004 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020334s004lbl.pdf 2010-08-20 00:00:00 AP 0 26276 012623 061 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf 2010-08-20 00:00:00 AP 0 26277 018609 044 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018609s044ltr.pdf 2010-08-20 00:00:00 AP 0 26278 021919 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021919_byetta_toc.cfm 2010-08-20 00:00:00 AP 0 26279 022134 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022134s000TOC.cfm 2010-08-23 00:00:00 AP 0 26280 012623 061 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf 2010-08-24 00:00:00 AP 0 26281 020334 004 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf 2010-08-24 00:00:00 AP 0 26282 020868 008 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf 2010-08-24 00:00:00 AP 0 26283 200196 000 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200196s000ltr.pdf 2010-08-24 00:00:00 TA 0 26284 050814 001 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050814s001ltr.pdf 2010-08-25 00:00:00 AP 0 26285 090829 000 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090829s000ltr.pdf 2010-08-26 00:00:00 TA 0 26286 022192 001 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022192s001ltr.pdf 2010-08-26 00:00:00 AP 0 26287 022081 016 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s016ltr.pdf 2010-08-26 00:00:00 AP 0 26288 021373 011 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021373s011ltr.pdf 2010-08-26 00:00:00 AP 0 26289 022192 001 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022192s001lbl.pdf 2010-08-27 00:00:00 AP 0 26290 021426 015 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021426s015lbl.pdf 2010-08-27 00:00:00 AP 0 26291 022545 000 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022545s000lbl.pdf 2010-08-27 00:00:00 AP 0 26292 021110 056 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf 2010-08-27 00:00:00 AP 0 26293 021083 046 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf 2010-08-27 00:00:00 AP 0 26294 090576 000 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/090576s000lbl.pdf 2010-08-27 00:00:00 AP 0 26295 018609 044 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018609s044lbl.pdf 2010-08-28 00:00:00 AP 0 26296 018814 032 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018814s032lbl.pdf 2010-08-28 00:00:00 AP 0 26297 020262 048 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020262s048lbl.pdf 2010-08-28 00:00:00 AP 0 26298 018766 015 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015lbl.pdf 2010-08-28 00:00:00 AP 0 26299 018766 015 Medication Guide http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018766s015MedGuide.pdf 2010-08-28 00:00:00 AP 0 26300 021770 004 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf 2010-08-28 00:00:00 AP 0 26301 021262 020 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021262s020,021770s004lbl.pdf 2010-08-28 00:00:00 AP 0 26302 021693 002 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021693s002lbl.pdf 2010-08-28 00:00:00 AP 0 26303 018147 032 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032lbl.pdf 2010-08-28 00:00:00 AP 0 26304 018147 032 Medication Guide http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018147s032MedGuide.pdf 2010-08-28 00:00:00 AP 0 26305 021572 033 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021572s033lbl.pdf 2010-08-28 00:00:00 AP 0 26306 103772 5258 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103772s5258lbl.pdf 2010-08-28 00:00:00 AP 0 26307 050821 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821_cefepime_toc.cfm 2010-08-30 00:00:00 AP 0 26308 050821 000 Summary Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050821s000SumR.pdf 2010-08-30 00:00:00 AP 0 26309 022502 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022502_differin_toc.cfm 2010-08-30 00:00:00 AP 0 26310 022502 000 Summary Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022502s000SumR.pdf 2010-08-30 00:00:00 AP 0 26311 022260 002 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022260s002ltr.pdf 2010-08-30 00:00:00 AP 0 26312 022545 000 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022545s000ltr.pdf 2010-08-31 00:00:00 AP 0 26313 021426 015 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021426s015ltr.pdf 2010-08-31 00:00:00 AP 0 26314 019596 034 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf 2010-08-31 00:00:00 AP 0 26315 021037 011 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf 2010-08-31 00:00:00 AP 0 26316 091575 000 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091575s000ltr.pdf 2010-08-31 00:00:00 AP 0 26317 021346 035 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 2010-08-30 00:00:00 AP 0 26318 021346 031 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 2010-08-30 00:00:00 AP 0 26319 021346 038 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 2010-08-30 00:00:00 AP 0 26320 021346 039 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021346_s31_s35_s38_s39lbl.pdf 2010-08-30 00:00:00 AP 0 26321 022083 008 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022083s008ltr.pdf 2010-08-31 00:00:00 AP 0 26322 021330 009 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021330s009ltr.pdf 2010-08-31 00:00:00 AP 0 26323 021444 037 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 2010-08-30 00:00:00 AP 0 26324 021444 036 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 2010-08-30 00:00:00 AP 0 26325 021444 033 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 2010-08-30 00:00:00 AP 0 26326 021444 030 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021444S-030S-033S-036S-037lbl.pdf 2010-08-30 00:00:00 AP 0 26327 020588 050 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 2010-08-30 00:00:00 AP 0 26328 021346 031 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 2010-09-01 00:00:00 AP 0 26329 021346 035 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 2010-09-01 00:00:00 AP 0 26330 021346 038 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 2010-09-01 00:00:00 AP 0 26331 021346 039 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021346s031,s035,s038,s039ltr.pdf 2010-09-01 00:00:00 AP 0 26332 022537 000 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022537s000ltr.pdf 2010-09-01 00:00:00 TA 0 26337 020588 049 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 2010-08-30 00:00:00 AP 0 26338 020588 046 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 2010-08-30 00:00:00 AP 0 26339 020588 043 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020588S-043S-046S-049S-050lbl.pdf 2010-08-30 00:00:00 AP 0 26340 020272 062 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 2010-08-30 00:00:00 AP 0 26341 020272 061 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 2010-08-30 00:00:00 AP 0 26342 020272 058 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 2010-08-30 00:00:00 AP 0 26343 020272 055 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020272S-055S-058S-061S-062lbl.pdf 2010-08-30 00:00:00 AP 0 26344 020263 035 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf 2010-08-30 00:00:00 AP 0 26345 022117 004 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf 2010-08-30 00:00:00 AP 0 26346 022117 003 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022117s003s004lbl.pdf 2010-08-30 00:00:00 AP 0 26348 022081 000 Other REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=28 2010-09-01 00:00:00 AP 0 26349 020632 000 Other REMS http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM224378.pdf 2010-09-01 00:00:00 AP 0 26353 020263 035 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020263s035ltr.pdf 2010-09-02 00:00:00 AP 0 26354 021257 018 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021257s018ltr.pdf 2010-09-02 00:00:00 AP 0 26355 021994 001 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021994s001ltr.pdf 2010-09-02 00:00:00 AP 0 26356 022184 000 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022184s000ltr.pdf 2010-09-02 00:00:00 AP 0 26357 022410 000 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022410s000ltr.pdf 2010-09-02 00:00:00 AP 0 26358 021067 003 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s003ltr.pdf 2010-09-02 00:00:00 AP 0 26359 021067 003 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf 2010-09-02 00:00:00 AP 0 26360 022514 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514_mirapex_er_toc.cfm 2010-09-03 00:00:00 AP 0 26361 022514 000 Summary Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514s000SumR.pdf 2010-09-03 00:00:00 AP 0 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00:00:00 AP 0 26570 022315 003 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022315s003lbl.pdf 2010-09-29 00:00:00 AP 0 26571 022499 001 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022499s001lbl.pdf 2010-09-29 00:00:00 AP 0 26572 022500 001 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022500s001lbl.pdf 2010-09-29 00:00:00 AP 0 26573 021526 012 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021526s012lbl.pdf 2010-09-29 00:00:00 AP 0 26574 021925 008 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021925s008lbl.pdf 2010-09-29 00:00:00 AP 0 26575 020403 018 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf 2010-09-29 00:00:00 AP 0 26577 020007 040 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf 2010-09-29 00:00:00 AP 0 26578 020781 013 Label 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00:00:00 AP 0 29601 022352 014 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022352s013s014lbl.pdf 2011-07-25 00:00:00 AP 0 29602 022527 002 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022527s002ltr.pdf 2011-07-25 00:00:00 AP 0 29603 022554 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554_xifaxan_toc_.cfm 2011-07-26 00:00:00 AP 0 29604 022554 000 Summary Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554Orig1s000SumR.pdf 2011-07-26 00:00:00 AP 0 29605 022573 000 Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573_norethindrone_ethinyl_toc.cfm 2011-07-26 00:00:00 AP 0 29606 022573 000 Summary Review http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022573Orig1s000SumR.pdf 2011-07-26 00:00:00 AP 0 29607 017858 034 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017858s034ltr.pdf 2011-07-26 00:00:00 AP 0 29608 017858 034 Label 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013790 021 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/013790s021ltr.pdf 2011-07-29 00:00:00 AP 0 29639 021395 033 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021395s033lbl.pdf 2011-07-29 00:00:00 AP 0 29640 020246 035 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020246s035ltr.pdf 2011-08-01 00:00:00 AP 0 29641 021395 033 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021395s033ltr.pdf 2011-08-01 00:00:00 AP 0 29642 008370 032 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/008370s032lbl.pdf 2011-08-01 00:00:00 AP 0 29643 007961 028 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007961s028lbl.pdf 2011-08-01 00:00:00 AP 0 29644 007409 041 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf 2011-08-01 00:00:00 AP 0 29645 020757 055 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s055lbl.pdf 2011-08-01 00:00:00 AP 0 29646 012104 032 Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/012104s032lbl.pdf 2011-08-01 00:00:00 AP 0 29647 022383 000 Other REMS http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM266276.pdf 2011-08-02 00:00:00 AP 0 29648 007409 041 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf 2011-08-02 00:00:00 AP 0 29649 007961 028 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf 2011-08-02 00:00:00 AP 0 29650 008370 032 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/007409s041,007961s028,008370s032ltr.pdf 2011-08-02 00:00:00 AP 0 29651 022110 000 Other REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=65 2011-08-02 00:00:00 AP 0 29652 020757 055 Letter http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s055ltr.pdf 2011-08-02 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