opened on: 16 Aug 2017, 23:51:07 _dta: 1. by Jean Roth , jroth@nber.org , 16 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: Applications.txt > 816.dta obs: 21,255 vars: 5 16 Aug 2017 23:51 size: 1,084,005 (_dta has notes) ------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------- applno long %12.0g FDA Application Number appltype str4 %9s Application Type applpublicnotes byte %8.0g ApplPublicNotes sponsorname str41 %41s SponsorName tecode byte %133.0g tecode Therapeutic Equivalence (TE) Code ------------------------------------------------------------------------------- Sorted by: applno 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 67 AT2 = 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 999 TBD = To Be Determined