_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: RegActionDate.txt obs: 129,014 vars: 9 15 Aug 2017 11:01 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 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