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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST90METHYSERGIDE MALEATEMETRONIDAZOLETABLET; ORALSANSERTSANDOZ PHARMS2MGTABLET; ORALFLAGHSEARLE2S0MG * SOOMGMETOCLOPRAMIDE HYDROCHLORIDEINJECTABLE; INJECTIONREGLANAH ROBINSEQ lOMG BASEI2MLMETYRAPONETABLET; ORALMETOPIRONECIBA PHARM2S0MGMETOCURINE IODIDEMETYROSINEINJECTABLE; INJECTIONMETUBINE IODIDEELI LILLY2MG/MLCAPSULE; ORALDEMSERMERCK SHARP & DOHME2S0MGMETOLAZONEMICONAZOLETABLET; ORALZAROXOLYNPENNWALT2.SMG * SMG * lOMGINJECTABLE; INJECTIONMONISTATJANSSEN PHARMlOMG/MLMETOPROLOL TARTRATETABLET; ORALLOPRESSORGEIGY PHARMSMETRIZAMIDEINJECTABLE; INJECTIONAMIPAQUEWINTHROP LISTER LINGSOMG * lOOMG3.7SGM/VIAL * 6.7SGM/VIALMETRIZOIC ACID; *MULTIPLE*SEE CALCIUM; MEGLUMINE; METRIZOIC ACIDMICONAZOLE NITRATECREAM; TOPICALMICATINORTHO PHARMCREAM; VAGINALMONISTAT-7ORTHO PHARMLOTION; TOPICALMICATINORTHO PHARMMINOCYCLINE HYDROCHLORIDE2X2X2'-CAPSULE; ORALMINOCINLEDERLE LABS/AM CYAN EQ SOMG BASE * EQ lOOMG BASE
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST91MINOCYCLINE HYDROCHLORIDEINJECTABLE; INJECTIONMINOCINLEDERLE LABS/AM CYAN EQ 100MG BASE/VIALSYRUP; ORALMINOCINLEDERLE LABS/AM CYAN EQ 50MG BASE/5MLMINOXIDILTABLET; ORALLONITENUPJOHNMITHRAMYCININJECTABLE; INJECTIONMITHRACINPFIZER LABSMITOMYCIN CINJECTABLE; INJECTIONMUTANYCINBRISTOL LABS/BMMITOTANETABLET; ORALLYSODRENBRISTOL LABS/BNMOLINDONE HYDROCHLORIDECAPSULE; ORALNOBANWDO LABS/DUPONTCONCENTRATE; ORALMOBANWOO LABS/DUPONT2.5MG * 10MG2.5MG/VIAL5MG/VIAL * 20MG/VIAL500NG5NG * lONG * 25NG20NG/NLASABAPAPAPAPAPAPAPAPMOLINDONE HYDROCHLORIDETABLET; ORALMOBANENDO LABS/DUPONTMONOBENZONEOINTMENT; TOPICALBENOQUINPAUL B ELDER 20Y.NADOLOLTABLET; ORALCORGARDER SQUIBB AND SONSNAFCILLIN SODIUM MONOHYDRATECAPSULE; ORALHALLPEHBEECHAM LABSUHIPEHWYETH LABS/AMHOINJECTABLE; INJECTIONHAFeILBRISTOL LABS/BMHALLPEHBEECHAM LABSUHIPEHWYETH LABS/AHHO5MG * 10MG * 25MG40MG * 80MG * 120MGEQ 250MG BASEEg 250MG BASEEg SOOMG BASE/VIAL *Eg lGM BASE/VIAL MEg 2GM BASE/VIAL * Eg 4GM BASE/VIALEg 500HG BASE/VIAL MEg 1GM BASE/VIAL * ~ 2GM BASE/VIALEQ 10GN BASE/VIALEg SOOMG BASE/VIAL *Eg lGM BASE/VIAL *EQ 2GM BASE/VIAL M EQ 4GM BASE/VIALPOWDER FOR RECONSTITUTION; ORALUNIPENWYETH LABS/AMHO EQ 250NG BASE/5NL
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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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j./APPROVED PRESCRIPTION DRUG PRODU
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-,----APPROVED PRESCRIPTION DRUG PR
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APPROVED PRESCRI~TIOHDRUG PRODUCTSD
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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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