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

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APPRbvED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST132THEOPHYLLINEELIXIR; ORALTHEOPHYllIHEAA NATL PHARM MFG/BARRE 80MG/15MlAA PHARM ASSOCIATES 80MG/15MlAA WEST-WARD 80MG/15MlSOLUTION; ORALTHEOLAIRRIKER LABS/3MSYRUP; ORALSLO-PHYLLIN-80DOONER LABSTABLET; ORALSLO-PHYLLINDOONER LABSTHEOLAIRRIKER LABS/3M80MG/15ML80MG/15MLIOOMG * 200MG125MG * 250MGTHEOPHYLLINE; *MULTIPLE*SEE MERSALYL SODIUM; THEOPHYLLINESEE PROCAINE MERETHOXYLLINE; THEOPHYLLINEAPTHIABENDAZOLESUSPENSION; ORALMINTEZOLMERCK SHARP & DOHMETABLET, CHEWABLE; ORALMINTEZOLMERCK SHARP & DOHMETHIAMINE HYDROCHLORIDEINJECTABLE; INJECTIONBETAlIH SELI lILLYTHIAMIHE HelBEL-MAR LABSCARTER-GLOGAU LABSD-M PHARMACEUTICALSDELL LABSELKINS-SINN/AHROBINSINVENEX PHARMS/MOGULNATCON CHEMICALPARKE-DAVIS/W-LVITARINE/WEST CHEMWYETH LABS/AMHOTABLET, CONTROLLED RELEASE; ORALAPSUSTAIREAPBC ROERIG/PFIZER IOOMG * 300MGAPTHEO-DURAPBC KEY PHARMS IOOMG * 300MGAP200.MGAPAPAfTHEOPHYLLINE SODIUM GLYCINATEAPAPELIXIR; ORALGLYNAZANFIRST TEXAS PHARMS EQ 162MG BASE/5ML THIAMYLAL SODIUMSYNOPHYLATECENTRAL PHARMACALTABLET; ORALASBRONDORSEY LABS/SANDOZGLYNAZANFIRST TEXAS PHARMSSYNOPHYLATECENTRAL PHARMACALEQ 165MG BASE/15MLEQ 150MG BASEEQ 162MG BASEEQ 165MG BASEINJECTABLE; INJECTIONSUR ITA LPARKE-DAVIS/W-LTHIETHYLPERAZINE MALATEINJECTABLE; INJECTIONTORECANSANDOZ PHARMS500MG/5ML500MGlOOMG/MllOOMG/ML MlOOMG/ML MlOOMG/ML MlOOMG/MLlOOMG/MLlOOMG/MLlOOMG/MLlOOMG/MLlOOMG/MLlOOMG/MLZOOMG/MLZOOMG/MLZOOMG/MLIGM/VIAL * 5GM/VIAL * IOGM/VIAL5MGIML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST1'3';.)THIETHYLPERAZINE MALEATETHIOTHIXENESUPPOSITORY; RECTALTORECANSANDOZ PHARMS10MGCAPSULE; ORALNAVANEROERIG/PFIZERIMG * 2MG * 5MG * 10MG * 20MGTABLET; ORALTORECANSANDOZ PH ARMSTHIOGUANINE10MGTHIOTHIXENE HYDROCHLORIDECONCENT?ATE; ORALNAVANEROERIG/PFIZEREQ 5MG BASE/MLTABLET; ORALTHIOGUANINEBURROUGHS WELLCOME40MGINJECTABLE; INJECTIONNAVANEROERIG/PFIZEREQ 2MG BASE/ML * EQ 5MG BASE/MLTHIOPENTAL SODIUMSUSPENSION; RECTALPENTOTHALABBOTT LABSTHIORIDAZINESUSPENSION; ORALMELLARIl-SSANDOZ PHARMSTHIORIDAZINE HYDROCHLORIDECONCENTRATE; ORALMELLARILSANDOZ PHARMSTABLET; ORALMELLARIlSANDOZ PHARMSTHIOTEPA400MG/GMEQ 25MG HCL/5ML * EQ 100MG HCL/5ML30MG/ML * 100MG/MLINJECTABLE; INJECTIONTHIO-TEPALEDERLE LABS/AM CYAN 15MG/VIAL10MG * 15MG * 25MG * 50MG * 100MG *150MG * 200MGTHONZONIUM BROMIDE; *MULTIPLE*SEE COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCINSULFATE; THONZONIUM BROMIDETHYROGLOBULINTABLET; ORALPROLOIDBP PARKE-DAVIS/W-LBPTHYROGLOBULINRICHLYN LABSTHYROTROPININJECTABLE; INJECTIONTHYTROPARARMOUR PHARMTICARCILLIN DISODIUMINJECTABLE; INJECTIONnCARBEECHAM LABS65MG16MG * 32MG * 100MG * 130MG *200MG * 325MG64.8MG10 UNITS/VIALEQ IGM BASE/VIAL *EQ 3GM BASE/VIAL * EQ 6GM BASE/VIAL
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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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APPROVED ¥RESCRIPTION DRUG PRODUCT
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'''"APPROVED PRESCRIPTION DRUG PROD
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----..//APPROVED PRESCRIPTION DRUG
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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