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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST70HYDROXYPROGESTERONE CAPROATEINJECTABLE; INJECTIONDURA-LUTiNAO CARTER-GLOGAU LABS 12SMG/ML M 2S0MG/MLHYDROXY PROGESTERONE CAPROATEAO MAURRY BIOLOGICAL 12SMG/MLAPAPAPAPAPAPHYDROXYSTILBAMIDINE ISETHIONATEINJECTABLE; INJECTIONHYDROXYSTILBAMIDINE ISETHIONATEMERRELL-NATIONAL 22SMG/VIALHYDROXYUREACAPSULE; ORALHYDREAER SQUIBB AND SONSHYDROXYZINE HYDROCHLORIDEINJECTABLE; INJECTIONHYDROXYZINE HCLABBOTT LABSCARTER-GLOGAU LABSELKINS-SINN/AHROBINSWYETH LABS/A~1HOORGATRAXORGANON/AKZONAVIsTARiLPFIZER LABSSOOMGSOMG/ML2SMG/ML M SOMG/Mt2SMG/ML M SOMG/ML2SMG/ML M SOMG/ML2SMG/ML M SOHG/ML2SMG/HL M SOMG/MLSYRUP; ORALATARAXAA ROERIG/PFIZER lOMG/SMLHYDROXYZINE HCLAA NATL PHARM MFG/BARRE lOMG/SMLTABLET; ORALATARAXROERIG/PFIZERIOMG * 2SMG * SOMG * IOOMGHYDROXYZINE PAMOATECAPSULE; ORALVISTARIlPFIZER LABSSUSPENSION; ORALVISTARIlPFIZER LABSIBUPROFENTABLET; ORALMOTRINUPJOHN MFGIDOXURIDINEOINTMENT; OPHTHALMICSTOXIlSKF LABSEQ 2SMG HCL * EQ SOMG HCL *EQ IOOMG HCLEQ 2SMG HCL/SHL300MG * 400MG * 600MGO.S:!SOLUTION/DROPS; OPHTHALMICDENDRiDAT ALCON LABSO.l?HERPLEXAT ALLERGAN PHARMS O.l?sTOXiLAT SKF LABSO.l?IMIPRAMINE HYDROCHLORIDEINJECTABLE; INJECTIONTOFRANIlGEIGY PHARMSTABLET; ORALANTI PRESSBP LEMMON PHARMACALIMAVATEAS AH ROBINSIMIPRAMIHE HCLAS BIOCRAFT LABS2SMG/2HL2SMG2SMG M SOMG10MG M 2SMG M SOMG~-'
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST71IMIPRAMINE HYDROCHLORIDETABLET; ORALIMIPRAMINE HClAB BOLAR PHARM lOMG * 25MG * 50MGAB CHELSEA LABS 25MG * 50MGAB CORD LABS lOMG * 25MG * 50MGABABBPABABBPABBPLEDERLE LABS/AM CYAN lOMG * 25MG * 50MGPHILIPS ROXANE LABS lOMG * 25MG * 50MGPREMO PHARM LABS 2SHGJAHIMIHEABBOTT LABSlOMG * 25MG * 50MGSK-PRAMIHESKF LABSlOMG * 25MGSOMGTOFRANILGEIGY PHARMSlOMG * 50MG2S~lGINSULIN, PURIFIED PORKINJECTABLE; INJECTIONIlETIN IIELI LILLY500 UNITS/MLINTRINSIC FACTOR; *MULTIPLE*SEE COBALT CHLORIDE, CO-S7; CYANOCOBALAMIN; CYANOCOBALAMIN,CO-S7; INTRINSIC FACTORSEE COBALT CHLORIDE, CO-60i CYANOCOBALAMIN; CYANOCOBALAMIN,CO-60; INTRINSIC FACTORINULININJECTABLE; INJECTIONINULINAMER CRIT CARE/AHSC100MG/MLIMIPRAMINE PAMOATECAPSULE; ORALTOFRANIL-PMGEIGY PHARMSEQ 75MG HCL * EQ IOOMG HCL *EQ 125MG HCL * EQ 150MG HCLINVERT SUGARINJECTABLE; INJECTIONTRAVERT lOX IN PLASTIC CONTAINERTRAVENOL LABS 10GM/IOOMLINDOCYANINE ~REENINVERT SUGAR; UREAINJECTABLE; INJECTIONCARDIO-GREENHYNSN IolSTCTT DUNNING IOMG/VIAL * 25MG/VIAL * 40MG/VIAL *50MG/VIALINJECTABLE; INJECTIONUREVERTTRAVENOl LABSIOGM/IOOML;4GM/IOOML * 10GM/IOOMl;30GM/IOOMLINDOMETHACINIOCARMATE MEGLUMINECAPSULE; ORALINDOCINMERCK SHARP & DOHME25MG * 50MGINJECTABLE; INJECTIONDIMERAYMALLINCKRODT608MG/MLINSULIN, PORKIOCETAMIC ACIDINJECTABLE; INJECTIONIlETINELI LILLYSOO UNITS/MLTABLET; ORALCHOLEBRINEMALLINCKRODT7S0MG
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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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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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