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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST106PIPERAZINE CITRATETABLET; ORALPIPERAZINE CITRATERICHLYN LABSPIPERAZINE ESTRONE SULFATECREAM; VAGINALOGENABBOTT LABSTABLET; ORALOGENABBOTT LABSPIPOBROMANTABLET; ORALVERcYTEABBOTT LABSEQ 250MG BASE1.5MG/GM750 UGN * 1.5MG * 3MG * 6MG10MG * 25MGPOLYMYXIN B SULFATE; *MULTIPLE*SEE BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE CHLORAMPHENICOL; POLYMYXIN B SULFATESEE GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE HYDROCORTISONE; POLYMYXIN B SULFATESEE NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATEPOL YTHIAZIDETABLET; ORALRENESEPFIZER LABSIMG * 2MG * 4MGPOLYTHIAZIDE; PRAZOSIN HYDROCHLORIDECAPSULE; ORALMINIZIDEPFIZER LABS500 UGM;lMG * 500 UGM;2MG * 500 UGM;5MGPOLYESTRADIOL PHOSPHATEPOLYTHIAZIDEi RESERPINEINJECTABLE; INJECTIONESTRADURINAYERST LABS/AMHO40HG/AMPTABLET; ORALRENESE-RPFIZER LABS2MG;250 UGMPOLYMYXIN B SULFATEINJECTABLE; INJECTIONPOLYMIXIN B SULFATEPFIZER LABS500,000 UNITS/VIALPOWDER; FOR RX COMPOUNDINGPOLY-RXPHARMA-TEK100,000,000 UNITS/VIALPOTASSIUM ACETATE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE;SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMACETATE; POTASSIUM CHLORIDE; SODIUM ACETATESEE DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUMACETATE; SODIUM CHLORIDESEE DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUMCHLORIDEPOLYMYXIN B SULFATE; *MULTIPLE*SEE BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE BACITRACIN ZINC; POLYMYXIN B SULFATEPOTASSIUM AMINOSALICYLATECAPSULE; ORALPASKALIUMGLENWOOD LABS500MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST107POTASSIUM AMINOSALICYLATEPOWDER; ORALPASKALrUMAA GLENWOOD LABS 3GM/PACKETPOTASS~UMAM~HOSAL~CYLATEAA MARSCHALl/MILES LABS 100?APTABLET; ORALPASKALIUMGLENWOOD LABSPOTASSIUM CHLORIDEINJECTABLE; INJECTIONPOTASS~UMABBOTT LABSCHLOR~DEAP AM MCGAW/AM HOSPAPAP CUTTER LABSAPAPAPELI LILLYELKINS-SINN/AHROBINS~ INT'L MEDICATION SYSAP INVENEX LABSAP INVENEX PHARMS/MOGULAP NATCON CHEMICALAP TORIGIAN LABSAP TRAVENOL LABSAPAP VITARINE/WEST CHEMSOOMG * IGMTABLET, CONTROLLED RELEASE; ORALK-TABBC ABBOTT LABS 7S0MGKAON-CLWARREN-TEED/ADRIAKLOTRIXSOOMGBC MEAD JOHNSON/BM 7S0MGSLOW-KCIBA PHARMlMEg/ML * 2MEQ/MLI.SMEQ/ML * 2.4MEQ/ML * 3.2MEQ/MLlMEg/ML * 2MEg/ML * 3MEg/Ml *4HEg/MllMEQ/Ml * 2MEg/Ml * 3MEQ/Ml *4MEg/Ml2HEg/Ml2MEg/Ml2MEg/MLZMEg/MlZMEg/Ml * !MEg/ML2ME(VMLZMEg/MllMEg/Ml * 2MEg/Ml * !MEg/Ml *4MEg/MlZHEg/HlSMEQ/ML600MGPOTASSIUM CHLORIDE; *MULTIPLE*SEE AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACIDiPOTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDESEE AMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMACETATE: POTASSIUM CHLORIDE; SODIUM ACETATESEE CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE iPOTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE;SODIUM L.ACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMCHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUMACETATE i SODIUM CHLORIDESEE CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUMCHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATESEE CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDESEE CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE;SODIUM LACTATESEE DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;POTASSIUM PHOSPHATE. MONOBASIC; SODIUM CHLORIDE; SODIUMLACTATESEE DEXTROSE: MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUMACETATE; SODIUM CHLORIDE; SODIUM GLUCONATESEE DEXTROSE; POTASSIUM CHLORIDESEE DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE - INPLASTICSEE MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE;SODIUM CHLORIDE; SODIUM GLUCONATEPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE; INJECTIONSODIUM CHLORIDE 0.9% & POTASSIUM CHLORIDE 0.07S% IN PLASTICCONTAINERTRAVENOL LABS 7SMG/I00ML;900MG/I00MLSODIUM CHLORIDE 0.97, & POTASSIUM CHLORIDE 0.157. IN PLASTICCONTAINERTRAVENOL LABS IS0MG/I00ML;900MG/I00MLSODIUM CHLORIDE 0.97. & POTASSIUM CHLORIDE 0.2247. IN PLASTICCONTAINERTRAVENOL LABS 224MG/I00ML;900MG/I00MLSODIUM CHLORIDE 0.97. AND POTASSIUM CHLORIDE 0.37. IN PLASTICCONTAINERTRAVENOL LABS 300MG/I00ML;900MG/I00ML
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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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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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