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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST8AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINETABLET; ORALTRIAVIL 4-10BP MERCK SHARP & DOHMETRIAVIL 4-25BP MERCK SHARP & DOHMETRIAVIL 4-50MERCK SHARP & DOHMEAMMONIUM CHLORIDEINJECTABLE; INJECTIONAMMONIUM CHLORIDEABBOTT LABSAM MCGAW/AM HOSP10MG;4MG25MG;4MG50MG;4MGAMMONIUM CHLORIDE; SODIUM CHLORIDE5MEQ/ML0.4MEQ/ML * 3MEQ/MLINJECTABLE; INJECTIONAMMONIUM CHLORIDE IN ISOTONIC SODIUM CHLORIDEAM MCGAW/AM HOSP 900MG/100MLi900MG/100MLAMMONIUM SALT OF C-12-C-15 LINEAR PRIMARY ALCOHOL ETHOXYLATEj*MULTIPLE*SEE ALKYL AMMONIUM SULFONIC ACID BETAINE (SULFOBETAINE DEH)jAMMONIUM SALT OF C-12-C-15 LINEAR PRIMARY ALCOHOLETHOXYLATEj EDETATE SODIUM; ETHOMEEN C-25jHEXACHLOROPHENE; LANOLIN ALCOHOLS. ACETYLATEDAMODIAQUINE HYDROCHLORIDETABLET; ORALCAMOQUIN HCLPARKE-DAVIS/W-LAMOXICILLIN TRIHYDRATECAPSULE; ORALAMOX:ICIL l:IHAB BIOCRAFT LABSEQ 200MG BASEEQ 250MG BASE * EQ 500MG BASEAMOXICILLIN TRIHYDRATECAPSULE; ORALAMOX:IC:ILL:IH TR:IHYDRATEAB FEDERAL PHARMACAL EQ 250MG BASE * EQ 500MG BASEAMOX:IlAB BEECHAM LABS EQ 250MG BASE * EQ 500MG BASECOMO XAB JOHN 0 COPANOS EQ 250MG BASE * EQ 500MG BASELAROT:IDAB HOFFMANN-LA ROCHE EQ 250MB BASE * EQ 500MB BASEPOlYMOXAB BRISTOL LABS/BM EQ 250MG BASE * EQ 500MG BASETR:IMOXAB ER sqUIBB AND SONS EQ 250MB BASE * EQ 500MG BASEUT:IMOXAB PARKE-DAVIS/W-L EQ 250HB BASE' *' EQ 500MG BASEWYMOXAB WYETH LABS/AMHO EQ 250MB BASE * EQ 500MG BASEPOWDER FOR RECONSTITUTION; ORALAMOX:ICILl:IHAS BIOCRAFT LABS EQ 125MB BASE/5ML *ABEg 250HG BASE/5MlAMOX:IC:Ill:IH TR:IHYDRATEAS JOHN 0 COPANOS Eg 125MB BASE/5ML *ABEg 250MB BASE/5MLAMOX:IlAB BEECHAM LABS Eg 125MB BASE/5ML ABEg 250MG BASE/5Ml * Eg 50MG BASE/MLLAROT:IDAS HOFFMANN-LA ROCHE EQ 125MG BASE/5Ml ABEQ 250MB BASE/5ML * Eg 50MG BASE/MLPOLYMOXAB BRISTOL LABS/BM EQ 125MG BASE/5ML *ASEg 50MG BASE/ML * Eg 250MG BASE/5MLTR:IMOXAB ER SQUIBB AND SONS Eg 125MG BASE/5ML *ABEg 250MG BASE/5MlABABASABUT:IMOXPARKE-DAVIS/W-LWYMOXWYETH LABS/AMHOEQ 125MG BASE/5ML *Eg 250MG BASE/SML * Eg 50MG BASE/MlEg' 12SMG BASE/SML *Eg 250MG BASE/SML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST9AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINEADIPATEi DEXTROAMPHETAMINE SULFATECAPSULEi ORALDELCOBESEDELCO CHEMICALTABLET; ORALDELCOBESEDELCO CHEMICAL1.2SMGil.2SMGil.2SMGil.2SMG * 2.SMG;2 .SMGi 2 .SNGi 2 .SMG * 3. 7SNG; 3. 7StIG;3.7SMGi3.7SMG * 5MG;SMG;SMG;SMG1.2SMGil.2SMG;1.25MG;1.2SMG * 2.SMG;2.SNG;2.SMGi2.5MG * 3.7SMG;3.7SMG;3. 7SMG;3. 7SMG * S~IG;SNG;SMG;SMGAMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXCAPSULE, CONTROLLED RELEASE; ORALBIPHETAMINE 12.SPENNWALTEQ 6.2SMG BASE;EQ 6.2SMG BASEBIPHETAMINE 20PENNWALTEQ lOMG BASE;EQ lOMG BASEBIPHETAMINE 7.SPENNWALTEQ 3.7SMG BASE;EQ 3.7SMG BASEAMPHETAMINE SULFATECAPSULE, CONTROLLED RELEASE; ORALI BENZEORINESKF LABSlSMGTABLET; ORALBENZEDRINESKF LABSSMG * lOMGAMPHETAMINE SULFATE; *NULTIPLE*SEE AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE;DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATEAMPHOTERICIN BCREAM: TOPICALFUNGIZONEER SQUIBB AND SONS 3%AMPHOTERICIN BINJECTABLE; INJECTIONFUNGIZONEER SQUIBB AND SONSLOTION; TOPICALFUNGI ZONEER SQUIBB AND SONS 3%OINTMENT: TOPICALFUNGIZONEER SQUIBB AND SONS 3%AMPICILLIN SODIUMINJECTABLE: INJECTIONAMCILL-SAP PARKE-DAVIS/W-LAPAPAPAMPICILLIN SODIUMAP JOHN D COPANOSAPAPAPOMNIPEN NAP WYETH LABS/AMHOAPAp·APPENBRITIN-SAP AYERST LABS/AMHOAPAPAPAPAPAPAPAPAPAPAPPOLYCILLIN-NBRISTOL LABS/BMTOTACILLIN-NBEECHAM LABSSOMG/VIALEQ 1Z5MG BASE/VIAL MEQ Z50MG BASE/VIAL MEg 500MG BASE/VIAL MEg 1GM BASE/VIALEg 1Z5MG BASE/VIAL MEg ZSOflG BASE/VIAL MEg SOOHG BASE/VIAL MEQ 16M BASE/V!AL M EQ ZGM BASE/VIALEg 1ZSMG BASE/VIAL MEg Z50MG BASE/VIAL MEg 500MG BASE/VIAL MEQ 1GM BASE/VIAL M EQ 2GM BASE/VIALEg 1ZSMG BASE/VIAL MEg 2S0MG BASE/VIAL MEQ SOOMG BASE/VIAL MEg 1GM BASE/VIAL M EQ 2GM BASE/VIALEQ 4GM BASE/VIALEg 125MG BASE/VIAL MEg 250MG BASE/VIAL MEg 500~!G BASE/VIAL MEg 1GM BASE/VIAL M ~Q 2GM BASE/VIALEg 12SMG BASE/VIAL MEg 2S0MG BASE/VIAL MEg 500MG BASE/VIAL MEQ 1GM BASE/VIAL M EQ 2GM BASE/VIAL
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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