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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST74ISONIAZIDISOPROTERENOL HYDROCHLORIDETABLET; ORALAEROSOL; INHALATIONISOHIAZIDISOPROTERENOL HCLAA PANRAY/ORMONT DRUG SOMG !If lOOMG !If 300MG BN RIKER LABS/3M 0.2SXAA PHARMAVITE PHARMS 100MGISUPRELAA PHOENIX LABS SOMG !If 100MGBN BREON LABS/STERLING 0.2SXAA PUREPAC PHARM SOMG !If 100MGNORISODRINE AEROTROLAA RICHLYN LABS 100MGBN ABBOTT LABS 0.2SXAA TOWNE PAULSEN 100MGAA WEST-W~RD 100MGINJECTABLE; INJECTIONAA ZENITH LABS lOOMG !If 300MGIPREHOLLAHIAZIOAP VITARINE/WEST CHEM 200 UGM/MLAA LANNETT SOMG !If lOOMGISOPROTEREHOL HCLHICOHYLAP ABBOTT LABS200 UGM/MLAA PARKE-DAVIS/W-L lOOMG20 UGM/MLHYORAZIOAP ELKINS-SINN/AHROBINS 200 UGM/MLAA ER SQUIBB AND SONS 100MGAP INT'L MEDICATION SYS 200 UGM/MLRIMIFOHISUPRELAA HOFFMANN-LA ROCHE SOMG !If lOOMGAP BREON LABS/STERLING 200 UGM/MLSTAHOZIOEAA STAN LABS PHARM lOOMG !If 300MGSUPERCIOIHAA VITARINE/WEST CHEM lOOMGAH2S0MG/lOOMLISONIAZID; *MULTIPLE*SEE AMINOSALICYLIC ACID; ISONIAZIDISONIAZID; RIFAMPINCAPSULE; ORALRIFAMATEDOW PHARMSISOPROPAMIDE IODIDETABLET; ORALDARBIDSKF LABSISOPROTERENOL HYDROCHLORIDEAEROSOL; INHALATIONISOPROTERENOL HCLBN NATL PHARM MFG/BARRE 0.2SI:ISOMG;300MGEQ SMG BASEAHAHAHAHSOLUTION; INHALATIONAEROLOHEELI LILLYIPREHOLINVENEX LABSISOPROTEREHOL HCLPARKE-DAVIS/W-LISUPRELBREON LABS/STERLINGVA PO-ISOFISONS. TABLET; SUBLINGUALISUPRELBREON LABS/STERLINGO.S;!O.2S;! M D.S;!D.S;!II:D.S;!IOMG * lSMGISOPROTERENOL HYDROCHLORIDE; *MULTIPLE*SEE ACETYLCYSTEINEj ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATEAEROSOL; INHALATIONDUO-t1EDIHALERRIKER LABS/3M4MG/M L; 6MG/M L
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST75APAPAPISOPROTERENOL SULFATEAEROSOL; INHALATIONMEDIHALER-ISORIKER LABS/3MPOWDER; INHALATIONNORISODRINEABBOTT LABSKANAMYCIN SULFATECAPSULE; ORALKANTREXBRISTOL LABS/BMINJECTABLE; INJECTIONKAHTREXBRISTOL LABS/BMKLEBCILBEECHAM LABSKETAMINE HYDROCHLORIDEINJECTABLE; INJECTIONKETALARPARKE-DAVIS/W-LKRYPTON, KR-SIMGAS; INHALATIONMPI KRYPTON SIM GAS GENERATORMEDI-PHYSICSN/ALACTULOSESYRUP; ORALCEPHULACAA HERRELL-NATIONALCHROHULACAA MERRELL-NATIONAL2HG/Ml * 4MG/Ml107. * 2S7.EQ SOOMG BASE75MG/2ML M 500MG/2ML M lGM/!MLEQ 75MG BASE/2ML MEQ 500MG BASE/2ML M EQ lGM BASE/!MLEQ 10MG BASE/ML * EQ SOMG BASE/ML *EQ 100MG BASE/HLlOGM/1SMLlOGM/15MlLANOLIN ALCOHOLS. ACETYLATED; *HULTIPLE*SEE ALKYL AMMONIUM SULFONIC ACID BETAINE (SULFOBETAINE DEHljAMMONIUM SALT OF C-12-C-lS LINEAR PRIMARY ALCOHOLETHOXYLATEj EDETATE SODIUM; ETHOMEEN C-2SjHEXACHLOROPHENE; LANOLIN ALCOHOLS, ACETYLATEOLEUCOVORIN CALCIUMINJECTABLE; INJECTIONLEUCOVORIN CALCIUMLEDERLE LABS/AM CYAN 3MG/ML * SOMG/VIALLEVALLORPHAN TARTRATEINJECTABLE; INJECTIONLORFANHOFFMANN-LA ROCHELEVARTERENOL BITARTRATEINJECTABLE; INJECTIONLEVOPHED BITARTRATEBREON LABS/STERLINGlMG/MLEQ lMG BASE/MLLEVARTERENOL BITARTRATEj PROCAINE HYDROCHLORIDEj PROPOXYCAINEHYDROCH LORIDEINJECTABLE; INJECTIONRAVOCAINE HCL AND NOVOCAIN WI LEVOPHEDCOOK-WAITE/STERLING EQ 0.033MG BASE/ML;27.;0.47.LEVODOPACAPSULE; ORALBENDOPABD ICN PHARMS 100MG * 2S0MG * SOOMGDOPARBD NORWICH-EATON PHARM 100MG * 2S0MG * SOOMGLARODOPABD HOFFMANN-LA ROCHE lOOMG * 2S0MG * SOOMGTABLET; ORALDOPARBD NORWICH-EATON PHARM 2S0HG * SOOMG
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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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