opened on: 16 Nov 2016, 23:51:34 _dta: 1. by Jean Roth , jroth@nber.org , 16 Nov 2016 2. NBER URL: http://www.nber.org/data/drugs-at-fda.html 3. Source Page: http://www.fda.gov/Drugs/InformationOnDrugs/ucm135821.htm 4. Source File URL: http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM054599.zip 5. Source Text File: application.txt > 16.dta obs: 20,594 vars: 12 16 Nov 2016 23:51 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 resolve > d 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 requiremen > ts 6 AB1,AB2,AB3,AB4 = Products meeting necessary bioequivalence requir > ements 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 re > solved by adequate evidence of bioequivalence 131 BD = actual or potential bioequivalence problems have not been re > solved by adequate evidence of bioequivalence 144 BP = actual or potential bioequivalence problems have not been re > solved by adequate evidence of bioequivalence 146 BS = actual or potential bioequivalence problems have not been re > solved by adequate evidence of bioequivalence 147 BT = actual or potential bioequivalence problems have not been re > solved by adequate evidence of bioequivalence 151 BX = actual or potential bioequivalence problems have not been re > solved by adequate evidence of bioequivalence