first edition (1980) of the Orange Book - FDA Law Blog

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST54ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; FERROUS FUMARATETABLETi ORAL-28LOESTRIN FE 1.S/30PARKE-DAVIS LABS/W-L 30 UGM;1.SMGi7SMGLOESTRIN FE 1/20PARKE-DAVIS LABS/W-L 20 UGM;lMG;7SMGNORLESTRIN FE 1/SOPARKE-DAVIS LABS/W-L SO UGM;lMGi7SMGNORLESTRIN FE 2.S/SOPARKE-DAVIS LABS/W-L SO UGMi2.SMGi7SHGETHOMEEN C-2Si *MULTIPLE*SEE ALKYL AMMONIUM SULFONIC ACID BETAINE (SULFOBETAINE DEH J;AMMONIUM SALT OF C-12-C-lS LINEAR PRIMARY ALCOHOLETHOXYLATEi EDETATE SODIUM; ETHOMEEN C-2SjHEXACHLOROPHENE; LANOLIN ALCOHOLS, ACETYLATEDETHOPROPAZINE HYDROCHLORIDETABLET; ORALPARSIDOLPARKE-DAVIS/W-L10MG * SOMG * 100MGETHINYL ESTRADIOL; NORGESTRELTABLETi ORAL-2lLOIOVRALWYETH LABS/AMHOOVRALWYETH LABS/AMHOTABLET; ORAL-28LO/OVRAL-28WYETH LABS/AMHOOVRAL-28WYETH LABS/AMHO30 UGM;300 UGMso UGH;SOO UGM30 UGM;300 UGMSO UGH;SOO UGMETHOSUXIMIDECAPSULEi ORALZARONTINPARKE-DAVIS/W-LSYRUP; ORALZARONTINPARKE-DAVIS/W-LETHOTOIN2S0MG2S0MG/SHLETHINYL ESTRADIOL; NORGESTREL; FERROUS FUMARATETABLET; ORAL-28LO/OVRAL-28 AND FERROUS FUMERATEWYETH LABS/AMHO 30 UGM;300 UGMi7SMGOVRAL-28 AND FERROUS FUMARATEWYETH LABS/AMHO SO UGM;SOO UGM;7SMGETHIODIZED OILINJECTABLE; INJECTIONETHIODOLE FOUGERA/BYK-GULDEN 997.TABLET; ORALPEGANONEABBOTT LABSETHOXZOLAMIDETABLET; ORALCARD RASEBP UPJOHNETHAMIDEBP ALLERGAN PHARMSETHYlESTRENOL2S0MG * SOOMGl2SMGl2SMGIfETHIONAMIDETABLET; ORALTRECATOR-SCIVES LABS/AMHO2S0MGELIXIR; ORALMAXI BOLINORGANON/AKZONA2HG/SML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST55ETHYlESTRENOLFENFLURAMINE HYDROCHLORIDETABLET; ORALMAXIBOLINORGANON/AKZONA2MGTABLET; ORALPONDIMINAH ROBINS20MGETHYNODIOL DIACETATEi *HULTIPLE*SEE ETHINYL ESTRADIOL; ETHYNODIOL DIACETATESEE ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE; FERROUS FUMARATEETHYNODIOL DIACETATE; MESTRANOLTABLET; ORAL-20OVULENSEARLETABLET; ORAL-21OVULEN-21SEARLETABLET; ORAL-28OVULEN-28SEARLEETIDOCAINE HYDROCHLORIDEINJECTABLE; INJECTIONDURANESTASTRA PHARM PRODS1MG;lOO UGM1MG;100 UGM1MG;100 UGM0.5:1. * 1:1.ETIDOCAINE HYDROCHLORIDE; *MULTIPLE*SEE EPTNEPHRINE; ETIDOCAINE HYDROCHLORIDEETIDRONATE DISODIUMTABLET; ORALDIDRONELPROCTER AND GAMBLE200MGFENOPROFEN CALCIUM DIHYDRATECAPSULE; ORALNALFONDISTA PRODS/LILLYTABLET; ORALNALFONDISTA PRODS/LILLYFENTANYl CITRATEINJECTABLE; INJECTIONSUBLIMAZEJANSSEN PHARMEQ 300MG BASEEQ 600MG BASE50 UGM/MLFENTANYL CITRATE; *MULTIPLE*SEE DROPERIDOL; FENTANYL CITRATEFERROUS CITRATE, FE-59INJECTABLE; INJECTIONFERROUS CITRATE FE 59MALLINCKRODT25 UCI/MLFERROUS FUMARATE; *MULTIPLE*SEE ETHINYL ESTRADIOL; ETHYNODIOL DIACETATEi FERROUS FUMARATESEE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; FERROUSFUMARATESEE ETHINYL ESTRADIOL; NORGESTREL; FERROUS FUMARATEFERROUS GLUCONATE; *MULTIPLE*SEE ASCORBIC ACID; FERROUS GLUCONATEj FOLIC ACID
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RXD AND DRUG ACMINISTRATIONAPProVED
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approved application, a list of app
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products that have been approved" i
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To assist the user in relating the
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an evaluatien of therapeutic equiva
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ioavailability data is required for
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B - Drug products that FDA does not
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and the rate of absorption.pharmace
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4. Erythromycin stearate Tablets -
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II. LISTINGSA. FORMAT GUIDEThis p..
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CURRENT STATUS - POSSIBLY EFFECTIVE
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DRUG ProDUCT EKAMPLESSingle Ingredi
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APPROVED PRESCRIPTION DRUG PRODUCTS
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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