opened on: 4 Jan 2017, 23:51:24 _dta: 1. by Jean Roth , jroth@nber.org , 4 Jan 2017 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: RegActionDate.txt > 0104.dta obs: 129,014 vars: 9 4 Jan 2017 23:51 size: 4,515,490 (_dta has notes) ------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------- applno long %12.0g FDA Application Number actiontypestr str2 %9s Action Type actiontype int %22.0g actiontype Action Type indoctypeseqno int %8.0g In Document Type Sequence Number duplicatecounter byte %8.0g Duplicate Counter actiondatetime str19 %19s Action Date actiondate byte %td Action Date doctype str3 %9s Application Document Type tecode byte %133.0g tecode Therapeutic Equivalence (TE) Code ------------------------------------------------------------------------------- Sorted by: applno indoctypeseqno duplicatecounter 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