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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST46AAAAAAAAAAAAAAAAAPAPAPAPAPAPAPAPDIPHENHYDRAMINE HYDROCHLORIDEELIXIR; ORALDXPHEHHYDRAMXHE HCLCORD lABSHEUN-NORWOOD lABSlANNETTlEDERlE lABS/AM CYANPHILIPS ROXANE lABSPRIVATE FORMULATIONSHYDRAMIHENATl PHARM MFG/BARRESK-DXPHEHHYDRAMXHESKF lABS12.SMG/SHLlZ.SMG/SHL12.SMG/SHLlZ.SHG/SHL12.SMG/SML12.SMG/SML12.SMG/SMLlZ.SMG/SMLINJECTABLE; INJECTIONBEHADRYLPARKE-DAVISIW-l lOMG/ML M SOMG/MLDXPHEHHYDRAMXHE HCLBEL-MAR lABSlOMG/MLCARTER-GlOGAU lABS lOMG/ML M SOMG/MLD-M PHARMACEUTICALS lOMG/MLElKINS-SINN/AHROBINS SOMG/MLINT'l MEDICATION SYS SOMG/MLVITARINE/WEST CHEM SOMG/MLWYETH lABS/AMHO SOMG/MLLIQUID; ORALFENYLHISTMAllARDTABLET; ORALFENYlHIST-25MAllARDDIPHENIDOl HYDROCHLORIDEINJECTABLE; INJECTIONVONTROlSKF lABSTABLET; ORALVONTROlSKF lABS12.5MG/5Ml2SMGEQ 20MG BASEIMLEQ 25MG BASEDIPHENOXYlATE HYDROCHLORIDE; *MUlTIPlE*SEE ATROPINE SULFATE; DIPHENOXYlATE HYDROCHLORIDEDIPHENYlPYRAlINE HYDROCHLORIDETABLET; ORALDIAFEN HClRIKER lABS/3MDIPIVEFRIN HYDROCHLORIDE2MGSOLUTION/DROPS; OPHTHALMICPRO PINEAllERGAN PHARMS O.IXDISOPYRAMIDE PHOSPHATECAPSULE; ORALNOR PACESEARLE PHARMSDISULFIRAMTABLET; ORALANTABUSEAYERST lABS/AMHODOBUTAMINE HYDROCHLORIDEINJECTABLE; INJECTIONDOBUTREXELI lIllYDOPAMINE HYDROCHLORIDEINJECTABLE; INJECTIONINTROPINAMER CRIT CARE/AHSCEQ IOOMG BASE * EQ ISOMG BASE250MG * SOOMGEQ 2S0MG BASE/VIAL40MGIMl * aOMG/Ml
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST47DOXAPRAM HYDROCHLORIDEDOXYCYCLINE HYCLATEINJECTABLE; INJECTIONDOPRAMAH ROBINS~OMG/MLTABLET; ORALVIBRA-TABSPFIZER LABSEQ IOOMG BASEDOXEPIN HYDROCHLORIDEDOXYCYCLINE MONOHYDRATECAPSULE; ORALADAPJ:HAD PENNWALTADABCONCENTRATE; ORALSINEQUANPFIZER LABSDOXORUBICIN HYDROCHLORIDEINJECTABLE; INJECTIONADRIAMYCINFARMITALIAEQ lOMG BASE * EQ 25MG BASE *EQ 50NG BASE * sg 7SNG BASE *Eg lOONG BASEEg lOMGBASE * Eg 25MG BASE *Eg SONG BASE *Eg lOONG BASEEQ IOMG BASE/MLIOMG/VIAL * SOMG/VIALPOWDER FOR RECONSTITUTION; ORALDOXYCHELAD RACHELLE LABS EQ 25MG BASE/5MLVJ:BRAMYCJ:HAB PFIZER LABS EQ 25MG BASE/5MLTABLET; ORALDECAPRYNMERRELL-NATIONAL 1~.SMG * 2SMGDOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDETABLET; ORALBENDECTINMERRELL-NATIONALIOMG;lOMGDOXYCYCLINE CALCIUMSUSPENSION; ORALVIBRAMYCINPFIZER LABSEQ SOMG BASE/SMLDROMOSTANOLONE PROPIONATEINJECTABLE; INJECTIONDROLBANELI LILLYSOMG/MLDOXYCYCLINE HYCLATECAPSULE; ORALDOXYCHEL HYCLATEAB RACHELLE LABSVJ:BRAMYC!HAS. PFIZER LABSINJECTABLE; INJECTIONVIBRAMYCINPFIZER LABS .Eg SONG BASE * Eg lOOMG BASEEg SONG BASE * Eg lOOMG BASEEQ lOOMG BASE/VIAL *EQ ~OOMG BASE/VIALDROPERIDOLINJECTABLE; INJECTIONINAPSINEJANSSEN PHARMDROPERIDOL; FENTANYL CITRATE~.SMG/MLINJECTABLE; INJECTIONINNOVARJANSSEN PHARM ~.SMG/ML;50 UGM/ML
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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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APPROVED PRESCRIPTION DRUG PRODUCTS
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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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