_dta: 1. by Jean Roth , jroth@nber.org , 12 Oct 2018 2. NBER URL: http://www.nber.org/data/fda-orange-book-data.html 3. Source Page: http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm 4. Source File URL: www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip 5. Source Text File: products.txt ingredient: 1. The active ingredient(s) for the product. 2. Multiple ingredients are in alphabetical order, separated by a semicolon. dfroute: 1. Dosage form;Route of Administration 2. The product dosage form and route separated by a semi-colon. The format is not all uppercase. trade_name: 1. The trade name of the product as shown on the labeling. applicant: 1. The firm name holding legal responsibility for the new drug application. 2. The firm name is condensed to a maximum twenty character unique string. strength: 1. The potency of the active ingredient. May repeat for multiple part products. appl_type: 1. New Drug Application Type The type of new drug application approval. 2. New Drug Applications (NDA or innovator) are "N". Abbreviated New Drug Applications (ANDA or generic) are "A". appl_no: 1. New Drug Application (NDA) Number The FDA assigned number to the application. Format is nnnnnn. product_no: 1. Product Number. The FDA assigned number to identify the application products. 2. Each strength is a separate product. May repeat for multiple part products. Format is nnn. tecode: 1. Therapeutic Equivalence (TE) Code 2. The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. appdate: 1. Approval Date. The date the product was approved as stated in the FDA approval letter to the applicant. 2. The format is Mmm dd, yyyy. 3. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982". rld: 1. Reference Listed Drug (RLD). The pioneer or innovator of the drug. 2. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. type: 1. The group or category of approved drugs. Format is RX, OTC, DISCN. appfull: 1. Applicant Full Name. The full name of the firm holding legal responsibility for the new drug application. obs: 35,702 vars: 18 12 Oct 2018 12:07 size: 32,453,118 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------------- ingredient str233 %233s * Ingredient dfroute str79 %79s * Dosage Form; Route doseform str47 %47s Dosage Form. (from dfroute) route str70 %70s Route of Administration. (from dfroute) trade_name str97 %97s * Trade Name (Proprietary Name) applicant str20 %20s * Applicant strength str206 %206s * Strength appl_type str1 %9s * Application Type appl_no long %12.0g * Application Number product_no byte %8.0g * Product Number tecodestr str15 %15s Therapeutic Equivalence (TE) Code String tecode float %140.0g tecode * Therapeutic Equivalence (TE) Code appdatestr str29 %29s Approval Date String appdate float %td appdate * Approval Date; 1982-01-01 = 'Approved Prior to Jan 1, 1982' rld str3 %9s * Reference Listed Drug rs str3 %9s RS type str5 %9s * Type appfull str88 %88s * Applicant Full Name * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: ingredient dfroute doseform route trade_name applicant strength appl_type appl_no product_no tecodestr tecode appdat > estr appdate rld rs type appfull 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 > bioequivalence 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 67 AT2 = 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 appdate: 8036 Approved Prior to Jan 1, 1982