_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: DocType_lookup.txt doctype: 1. doctype_lookup has doctype and doctypedesc which is the source of the labels obs: 57 vars: 4 15 Aug 2017 11:04 size: 3,249 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------------------------- doctype long %53.0g doctype * Application Document Type doctypestr str3 %9s Application Document Type doctypedesc str49 %49s Document Type Description tecode byte %133.0g tecode Therapeutic Equivalence (TE) Code * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: doctype doctype: 2 B Biopharmaceutics 13 M Presubmission 14 N Approval 16 P Periodic Safety Report 19 S Supplement 25 Y Annual Report 1902 SB SBA 1903 SC Chemistry 1904 SD 1905 SE 1906 SF Final Printed Labeling (MarkIV) 1912 SL Labeling 1915 SO Other 1916 SP 1918 SR 1919 SS Microbiology 2001 TA Tentative Approval 19051 SE1 New or Modified Indication 19052 SE2 New Dosage Regimen 19053 SE3 New Route of Administration 19054 SE4 Comparative Efficacy Claim 19055 SE5 Patient Population Altered 19056 SE6 OTC Labeling 19057 SE7 Accelerated Approval 19058 SE8 Efficacy Supplement with Clinical Data to Support 19059 SE9 190301 SCA Packaging Addition 190302 SCB Facility Addition 190303 SCC Supplier Addition 190304 SCD Packager Addition 190305 SCE Expiration Date Change 190306 SCF Formulation Revision 190307 SCG Chemistry Generic 190308 SCH 190309 SCI Chemistry in Effect 190310 SCJ 190311 SCK 190312 SCL 190313 SCM Manufacturing Change or Addition 190314 SCN 190315 SCO 190316 SCP Package Change 190317 SCQ Chemistry New Strength 190318 SCR Manufacturing Revision 190319 SCS Control Supplement 190320 SCT 190321 SCU 190322 SCV 190323 SCW 190324 SCX Chemistry Expedite 190325 SCY 190326 SCZ 190403 SDC ??? 190419 SDS Distributor 190504 SED Efficacy (MarkIV) 190506 SEF ??? 190519 SES General Efficacy (MarkIV) 190616 SFP Final Printed Labeling - MarkIV 191201 SLA Labeling (MarkIV) 191209 SLI Labeling in Effect 191213 SLM Labeling (MarkIV) 191218 SLR Labeling Revision 191219 SLS Labeling (MarkIV) 191224 SLX Labeling Expedite 191501 SOA Other Amendment 191604 SPD Practioner Draft Labeling 191606 SPF Practioner Draft Labeling 191803 SRC Resubmission - Chemistry (MarkIV) 191805 SRE Resubmission - Efficacy (MarkIV) 191815 SRO Resubmission - Other (MarkIV) 191901 SSA Supplement Amendment (MarkIV) 191916 SSP Supplement Pediatric (MarkIV) 191918 SSR Supplement Resubmission (MarkIV) 191923 SSW Supplement Withdrawal (MarkIV) 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