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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST28CHLORPROMAZINE HYDROCHLORIDESUPPOSITORY; RECTALTHORAZINESKF LABSSYRUP; ORALSOHAZIHEAA CORD LABSTHORAZIHEAA SKF LABS2SNG * 100NG10MG/5MLlOMG/5MLTABLET; ORALCHLORPROMAZINE HCLBP CHELSEA LABS2SNG * SONGBP CORD LABSlONG * 2SNG * SONG * 100NG * 200NGBP GENERIC PHARM/IVY lONG * 2SNG * SOMG * 100MG * 200NGBP KV PHARMACEUTICAL lONG * 2SNG * SONG * 100MG * 200MGBP LEDERLE LABS/AN CYAN 10MG * 2SMG * SOMG * lOOMG * 200MGBP PHILIPS ROXANE LABS lOMG 2SMG SOMG * 100MG * 200MGBP . PRIVATE FORNULATIONS 2SMG * SOMG * 200MGBP PUREPAC PHARM lONG * 2SNG * SONG * 100MG * 200MGBP WESTERN RES LABS IOMG * 2SNG * SONG * 100MG * 200MGBP ZENITH LABSlONG * 2SNG * SONG * IOONG * 200NGTHORAZINEBP SKF LABSlONG * 2SNG * SONG * 100NG * 200NGCHLORPROTHIXENETABLET; ORALTARACTANHOFFMANN-LA ROCHECHLORTETRACYCLINE HYDROCHLORIDEOINTNENT; OPHTHALNICAUREONYCINLEDERLE LABS/AN CYAN IXCHLORTHALIDONETABLET; ORALHYGROTONUSV LABSlONG * 25NG * 50NG * 100NG2SNG * 50NGCHLORTHALIDONEj CLONIDINE HYDROCHLORIDETABLET; ORALCONBIPRESBOEHRINGER INGElHEIM l5NG; 100 UGN * l5tlG; 200 UGNCHLORPROPAMIDECHLORTHALIDONEj RESERPINETABLET; ORALCHlORPROPAM'IUEAS PR EttO PHARM LABSDIAB:tHESEAS PFIZER LABSCHLORPROTHIXENEINJECTABLE; INJECTIONTARACTANHOFFMANN-LA ROCHEZ50MGZ5tlHGIOOMG12.5NG/NLTABLET; ORALDEMI-REGROTONUSV LABSREGROTONUSV LABSCHLORZOXAZONETABLET; ORALPARAFLEXMCNEIL LABS25MG;l25 UGN50NG;250 UGN2S0NGLIQUID; ORALTARACTANHOFFMANN-LA ROCHE100MG/5MLCHOLESTYRAMINEPOWDER; ORALQUESTRANMEAD JOHNSON/BNEQ 4GN RESIN/PACKET
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST29CHROMIC PHOSPHATE, P-32CLEMASTINE FUMARATEINJECTABLE; INJECTIONPHOSPHOCOL P 32HALLINCKRODTCHYMOTRYPSIN5MCIIMLTABLET; ORALTAVISTDORSEY LABS/SANDOZTAVIST-lDORSEY LABS/SANDOZ2.68MG1.34MGPOWDER FOR RECONSTITUTION; OPHTHALMICALFHA CHYMARAT ARMOUR PH ARM 750 UHITS/VIALCATARASESMITH MILLER PATCH 150 UNITS/VIAL * 300 UNITS/VIALATilllliALCON LABS 750 UIfITS/VIALClIDINIUM BROMIDECAPSULE; ORALQUARZANHOFFMANN-LA ROCHE2.5MG * 5MGCLINDAMYCIN HYDROCHLORIDE HYDRATECIMETID!NETABLET; ORALTAGANETSK&F LAB COCIMETIDINE HYDROCHLORIDEINJECTABLE; INJECTIONTAGANETSK&F LAB COLIQUID; ORALTAGAMETSKF LABSCINOXACINCAPSULE; ORALCINOBAC- ELI lILLYCISPLATININJECTABLE; INJECTIONPLATINOLBRISTOL LABS/BM200NG * 300MGEQ 300MG BASE/2MLEQ 300MG BASE/5ML250MG * 500MGlONG/VIALCAPSULE; ORALCLEOCINUPJOHN NFGCLINDANYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE * EQ l50MG BASE-POWDER FOR RECONSTITUTION; ORALCLEOCINUPJOHN MFGEQ 75NG BASE/5NLCLINDAMYCIN PHOSPHATEINJECTABLE; INJECTIONCLEOCINUPJOHN MFGCLOCORTOLONE PIVALATECREAN; TOPICALCLODERNORTHO PHARMCLOFIBRATECAPSULE; ORALATROMID-SAYERST LABS/AMHOEQ 150MG BASE/NLO.l?500NG
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RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
Page 12 and 13: products that have been approved" i
Page 14 and 15: To assist the user in relating the
Page 16 and 17: an evaluatien of therapeutic equiva
Page 18 and 19: ioavailability data is required for
Page 20 and 21: B - Drug products that FDA does not
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Page 24 and 25: 4. Erythromycin stearate Tablets -
Page 27 and 28: II. LISTINGSA. FORMAT GUIDEThis p..
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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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