_dta: 1. by Jean Roth , jroth@nber.org , 15 Aug 2017 2. NBER URL: http://www.nber.org/data/drugs-at-fda.html 3. Source Page: http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm 4. Source Page #2: http://www.fda.gov/Drugs/InformationOnDrugs/ucm135821.htm 5. Source File URL: http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM527389.zip 6. Source Text File: application.txt obs: 20,594 vars: 12 15 Aug 2017 11:03 size: 1,359,204 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------------------------- applno long %12.0g FDA Application Number appltype byte %40.0g appltype Application Type appltypestr str1 %9s Application Type sponsorapplicant str41 %41s Sponsor Applicant mostrecentlabelavailableflag str5 %9s Most Recent Label Available Flag currentpatentflag str5 %9s Current Patent Flag actiontypestr str2 %9s Action Type actiontype int %22.0g actiontype Action Type chemical_type byte %8.0g Chemical Type ther_potential str2 %9s Therapeutic Potential orphan_code str1 %9s Orphan Code tecode byte %133.0g tecode Therapeutic Equivalence (TE) Code ------------------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: applno orphan_code appltype: 1 Abbreviated New Drug Applications (ANDA) 2 Biologic License Application (BLA) 14 New Drug Applications (NDA) actiontype: 6580 AP - Approval 8465 TA - Tenative Approval tecode: 1 AA = no known or suspected bioequivalence problems 2 AB = actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequi 3 AB1 = Products meeting necessary bioequivalence requirements 4 AB1,AB2 = Products meeting necessary bioequivalence requirements 5 AB1,AB2,AB3 = Products meeting necessary bioequivalence requirements 6 AB1,AB2,AB3,AB4 = Products meeting necessary bioequivalence requirements 7 AB1,AB3 = Products meeting necessary bioequivalence requirements 20 AB2 = Products meeting necessary bioequivalence requirements 30 AB3 = Products meeting necessary bioequivalence requirements 40 AB4 = Products meeting necessary bioequivalence requirements 50 AN = no known or suspected bioequivalence problems 51 AO = no known or suspected bioequivalence problems 52 AP = no known or suspected bioequivalence problems 56 AT = no known or suspected bioequivalence problems 66 AT1 = no known or suspected bioequivalence problems 130 BC = actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence 131 BD = actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence 144 BP = actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence 146 BS = actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence 147 BT = actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence 151 BX = actual or potential bioequivalence problems have not been resolved by adequate evidence of bioequivalence