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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST30CLOMIPHENE CITRATETABLET; ORALCLOMIDMERRElL-NATIONALCLONAZEPAMTABLET; ORALCLONOPINHOFFMANN-LA ROCHESOMGSOO UGM * IMG * 2MGCLOTRIMAZOLECREAM; TOPICALLOTUM::tHAT SCHERING l?MYCELEXAT DOME LABS/MILES LABS lZCREAM; VAGINALGYHE-LOTR::tM::tHAT SCHERING lZMYCELEX-GAT DOME LABS/MILES LABS lZCLONIDINE HYDROCHLORIDETABLET; ORALCATAPRESBOEHRINGER INGELHEIM 100 UGM * 200 UGM * 300 UGMCLONIDINE HYDROCHLORIDE; *MULTIPLE*SEE CHLORTHALIDONEi CLONIDINE HYDROCHLORIDECLORAZEPATE DIPOTASSIUMSOLUTION; TOPICALLOTRIMntAT SCHERING lZMYCELEXAT DOME LABS/MILES LABS lZTABLET; VAGINALGYHE-LOTR::tM::tHAT SCHERING lOOMGMYCELEX-GAT DOME LABS/NILES LABS lOOMGCAPSULE; ORALTRANXENEABBOTT LABSTABLET; ORALTRANXENE SOABBOTT LABSCLORAZEPATE MONOPOTASSIUMCAPSULE; ORALAZENEABBOTT LABSCLORTERMINE HYDROCHLORIDE3.7SMG * 7.SMG * lSMG11.2SMG * 22.SMG3.25MG * 6.5MG * 13MGADABABCLOXACILLIN SODIUM MONOHYDRATECAPSULEj ORALCLOXAC::tLLIH SOD rUMBIOCRAFT LABSCLOXAPEHBEECHAM LABSTEGOPEHBRISTOL LABS/BMEq 2S0MG BASE M EQ SOOMG BASEEQ 2S0MG BASE M EQ SOOMG BASEEQ 2S0MG BASE M EQ SOOMG BASEPOWDER FOR RECONSTITUTION; ORALTEGOPENBRISTOL LABS/BM EQ 12SMG BASE/SMLCOBALT CHLORIDE, CO-S7; CYANOCOBALAMIN; CYANOCOBALAMIN, CO-S7;INTRINSIC FACTORTABLET; ORALVORANILUSV PHARMSOMGN/A; N/ARUBRATOPE-57 KITER SQUIBB AND SONSN/AjN/A;N/A;N/A
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST31COBALT CHLORIDE, CO-60i CYANOCOBALAMIN; CYANOCOBALAMIN, CO-60;INTRINSIC FACTORN/A; N/ARUBRATOPE-60 KIT'ER SQUIBB AND SONSN/AiN/AiN/AiN/ACOLISTIN SULFATESUSPENSION; ORALCOLY-MYCIN SPARKE-DAVIS/W-LEQ 25MG BASE/SMLCODEINE PHOSPHATE; *MULTIPLE*SEE ACETAMINOPHEN; ASPIRINi CODEINE PHOSPHATESEE ACETAMINOPHEN; CODEINE PHOSPHATESEE CAFFEINE; CARISOPRODOL; CODEINE PHOSPHATE; PHENACETINCOLCHICINE; PROBENECIDTABLET; ORALCOL-PROBENECIDBP DANBURY PHARMACAL 500 UGM;500MGCOLBENENIDBP MERCK SHARP & DOHNE 500 UGMiSOOMGPROBEN-CBP CHELSEA LABS 500 UGMi500MGPROBENECID AND COLCHICINEBP BEECHAM LABS 500 UGM;500MGBP RICHLYN LABS 500 UGMi500MGBP ZENITH LABS 500 UGMi500MGPROBENECID WI COLCHICINEBP BOLAR PHARM 500 UGM;500MGBP LEDERLE LABS/AM CYAN 500 UGMj500MGBP PREMO PHARM LABS 500 UGNi500MGCOLESTIPOL HYDROCHLORIDEPOWDER; ORALCOLESTIDUPJOHNCOLISTIMETHATE SODIUMINJECTABLE; INJECTIONCOLY-MYCIN MPARKE-DAVIS/w-L5GM/PACKETEQ lS0MG BASE/VIALCOLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE;THONZONIUM BROMIDESUSPENSION; OTICCOLY-MYCIN SPARKE-DAVIS/W-LCOPPERINTRAUTERINE DEVICE; INTRAUTERINECOPPER TPOPULATION COUNCIL 120MGCU-7SEARLE PHARMS89MGTATUM-TSEARLE PHARMS 120MGCORTICOTROPINEQ 3MG BASE/MLjl0MG/ML;EQ 3.3MG BASE/ML;SOO UGM/MLINJECTABLE; INJECTIONACTHAP PARKE-DAVIS/W-L 25 UHZTS/VZAL M 40 UHZTS/VZALACTHARAP ARtl0UR PHARM 25 UHZTS/VZAL M 40 UHZTS/VZALAPCORTICOTROPIHORGANICSH.P. ACTHAR GEL40 UHITS/NL * 80 UHITS/NLBC ARMOUR PHARM 40 UNITS/ML * 80 UNITS/MLPURIFIED CORTROPHIN GELBC ORGANON/AKZON.4 40 UNITS/ML * 80 UNITS/MLREPOSITORY CORTICOTROPINBC WYETH LABS/AMHO 40 UNITS/ML * 80 UNITS/MLCORTICOTROPIN; ZINC HYDROXIDEINJECTABLE; INJECTIONCORTROPHIN-ZINCORGANON/AKZONA40 UNITS/MLi2MG/ML
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RXD AND DRUG ACMINISTRATIONAPProVED
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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
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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