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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST52ESTROGENS, CONJUGATEDTABLET; ORALCONJUGATED ESTROGENSBS CORD LABS 625 UGM 1.25MG * 2.5MGBS HEATHER DRUG 625 UGN * 1.25MG * 2.5MGBS ICN PHARMS 300 UGN * 625 UGM * 1.25MG * 2.5MGBS PRIVATE FORMULATIONS 625 UGM 1.25MG * 2.5MGBS ZENITH LABS 625 UGM * 1.25MG * 2.5MGPREMARINBS AYERST LABS/AMHO 300 UGM * 625 UGM * 1.25MG * 2.5MGESTROGENS, CONJUGATED; *MULTIPLE*SEE CHLORDIAZEPOXIDE; ESTROGENS, CONJUGATEDESTROGENS, CONJUGATED; MEPROBAMATETABLET; ORALMIlPREM-200BS WALLACE PHARMS/C-W 400 UGM;200MGMILPREM-400BS WALLACE PHARMS/C-W 400 UGM;400MGPMB 200BS AYERST LABS/AMHO 400 UGM;200MGPMB 400BS AYERST LABS/AMHO 400 UGM;400MGESTROGENS, ESTERIFIEDTABLET; ORALAMNESTROGENBS ER SQUIBB AND SONS 625 UGM * 1.25MG * 2.5MGESTERIFIED ESTROGENSBS CORD LABS 1.25MGBSPRIVATE FORMULATIONS 625 UGM * 1.25MG * 2.5MGESTRATABBS REID-PROVIDENT LABS 625 UGM * 1.25MG * 2.5MGEVEXBS SYNTEX LABS 625 UGM * 1. 25MGBSFEMOGENPRIVATE FORMULATIONS 625 UGM * 1.25MG * 2.5HGGLYESTRINBS FIRST TEXAS PHARMS 625 UGM * 1.25MG * 2.5MGESTROGENS, ESTERIFIEDTABLET; ORALMENESTBS BEECHAM LABS 625 UGM * 1.25MG * 2.5MG300 UGMESTRONEINJECTABLE; INJECTIONESTROGENIC SUBSTANCEBP AYERST LABS/AMHO 2MG/MLESTRONEBP CARTER-GLOGAU LABS 2MG/ML * 5MG/MLTHEELINBP PARKE-DAVIS/W-L 2MG/ML * 5MG/MLIMG/MLETHACRYNATE SODIUMINJECTABLE; INJECTIONEDECRINMERCK SHARP & DOHMEETHACRYNIC ACIDTABLET; ORALEDECRINMERCK SHARP & DOHMEETHAMBUTOL HYDROCHLORIDEEQ 50MG BASE/VIAL25MG * 50MGTABLET; ORALMYAMBUTOLLEDERLE LABS/AM CYAN IOOMG * 200MG * 400MG * 500MGETHCH LORVYNO LCAPSULE; ORALETHCHLORVYHOLAABANNER GELATIN PRODS lOOMG * 200MG * SOOMG * 7S0MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST53ETHCHLORVYNOLCAPSULE; ORALPLACIDYLAA ABBOTT LABSlOOMG If 200MG If SOOMG If 7S0MGETHINYL ESTRADIOL; FLUOXYMESTERONETABLETj ORALHALODRINUPJOHN ~O UGMilMGETHINAHATECAPSULE; ORALVALHIDDISTA PRODS/LILLYETHINYL ESTRADIOLTABLET; ORALESTINYLBP SCHERINGBPBPFEMINONEUPJOHNLYNORALORGANON/AKZONA500HG50 UGM~O UGM * 500 UGM50 UGM50 UGM10 UGHETHINYL ESTRADIOL; ETHYNODIOL DIACETATETABLETj ORAL-~1DEMULENSEARLETABLET; ORAL-28DEMULEN-28SEARLE50 UGMjlHG50 UGM;IMGETHINYL ESTRADIOL; ETHYNODIOl DIACETATEj FERROUS FUMARATETABLET; ORAl-28DEMULEN-FE-28SEARLE50 UGMilMGj75MGETHINYL ESTRADIOLj NORETHINORONETABLET; ORAL-21BREVICOH 21AS SYNTEXCF P) 35 UGI't;soo UGMMODICOHAS ORTHO PHARM 35 UGM;500 UGMORTHO-NOVUM 1/35-~1OR-THO PHARH35 UGMilMGOVCON-35MEAD JOHNSON LABS 35 UGMj400 UGHOVCON-50MEAD JOHNSON/BM 50 UGMjlMGTABLET; ORAL-~8BREVICOH 28AB SYNTEXCF P) 35 UGM;!OO UGMMODICOH 28AB ORTHO PHARM 35 UGM;500 UGMORTHO-NOVUM 1/35-~8ORTHO PHARH35 UGMilHGOVCON-35MEAD JOHNSON/13M 35 UGMj400 UGMOVCON-50MEAD JOHNSON/BM 50 UGHilMGETHINYL ESTRADIOL; NORETHINDRONE ACETATETABLETj ORAL-21LOESTRIN 1.5/30PARKE-DAVIS LABS/W-L 30 UGMjl.5MGLOESTRIN 21 1/20PARKE-DAVIS LABS/W-l 20 UGMjlHGNORLESTRIN ~1 1/50PARKE-DAVIS LABS/W-L 50 UGHjlMGNORLESTRIN 21 2.5/50PARKE-DAVIS LABS/W-l 50 UGMj2.5MGTABLET; ORAL-~8NORLESTRIN ~8 1/50PARKE-DAVIS LABS/W-L 50 UGMilMG
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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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PERCORTEN PIVALATE, DESOXYCORTICOST
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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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