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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST102PENTOBARBITALPERPHENAZINEELIXIR; ORALNEMBUTALABBOTT LABSlS.2MG/SMLCONCENTRATE; ORALTRIlAFONSCHERING16MG/5MLPENTOBARBITAL SODIUMCAPSULE; ORALNEMBUTAL SOnIUMAA ABBOTT LABSAAAAAAAAAAAAAAAAAAAAAAAt.AAAAAAAt.PEHTOBA~BITAL SOnIUMLANNETTLEMMON PHARMACALTOWNE PAULSENVITARINE/WEST CHEMsonIUM PEHTOBA~BITAlANABOLICBElL PHARMACALCHELSEA LABSHALSEY DRUGICN.PHARMSKETCHUM LABSPARKE-DAVIS/W-LPUREPAC PHARMSTAN LABS PHARMWEST-WARDWYETH LABS/AMHOZENITH LABSSliMS * lOOMS30MGSOMG * lOOMGlOOMSlOOMGlOOMSlOOMSlOOMGlOOMGlOOHGlOOMGlOOHGlOOMSlOOMGlOOMGlOOHSlOOMGSOMG * lOOMSINJECTABLE; INJECTIONHEMBUTAL SOnIUMAP ABBOTT LABS SOMS/MlPENTOBA~BITAl SODIUMAP ElKINS-SINN/AHROBINS SOMG/MlAP VITARINE/WEST CHEM SOMG/MlSODIUM PENTOBA~BITAlAP WYETH LABS/AMHO SOMS/MLTABLET; ORALPENTOBA~BITAL SODIUMAA VITARINE/WEST CHEM lOOMGSODIUM PENTOBARBITALAA ANABOLIC lOOMSINJECTABLE; INJECTIONTRILAFONSCHERINGSYRUP; ORALTRIlAFONSCHERINGTABLET; ORALTRIlAFONSCHERINGSMG/ML2MG/5MLTABLET, CONTROLLED RELEASE; ORALTRILAFONSCHERING8MG2MG * 4MG * 8MG * 16MGPERPHENAZINE; *MULTIPLE*SEE AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINEPHENACEMIDETABLET; ORALPHENURONEABBOTT LABS500MGPHENACETIN; *MULTIPLE*SEE ACETAMINOPHEN; PHENACETIN; PHENYLPROPANOLAMINEHYDROCHLORIDE; PHENYLTOLOXAMINE CITRATESEE ASPIRIN; BUTALBITAL; CAFFEINE; PHENACETINSEE ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE; PHENACETINSEE ASPIRIN; CAFFEINE; PHENACETIN; PROPOXYPHENE HYDROCHLORIDESEE CAFFEINE; CARISOPRODOL; CODEINE PHOSPHATE; PHENACETINSEE CAFFEINE; CARISOPRODOL; PHENACETINAAPHENDIMETRAZINE TARTRATECAPSULE; ORALPHENAZIHEMM MAST 3SMB
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST103PHENDIMETRAZINE TARTRATEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAACAPSULE; ORALPHEHDIMETRAZIHE TARTRATECORD LABS35MGVITARINE/WEST CHEM 35MGSTATOBEXLEMNON PHARMACAL 35MGCAPSULE, CONTROLLED RELEASE; ORALPHENDIMETRAZINE TARTRATEVITARINE/WEST CHEM I05MGTABLET; ORALADF'HEHFERNDALE LABS35MGALPHAlrHEVITARINE/WEST CHEM . 35MGCAM-METRAZIHECAMALL35MGDI-METREXPRIVATE FORMULATIONS 35MGMELFIATREID-PROVIDENT LABS 35MGMETRAOJF #2/CHROMALLOY 35MGPHEHAZIHE-35CAMALL35MGPHEHDIMETRAZIHE TARTRATEANABOLIC35MGBARR LABS35MGCAMALL35HGCHELSEA LABS35HGCORD LABS35HGGENERIC PHARM/IVY 35HGHEUN-NORWOOD LABS 35HGINWOOD LABS/FOREST 35HGKV PHARMACEUTICAL 35MGLEMMON PHARMACAL 35MGMANUFACTURING CHEM 35HGPRIVATE FORMULATIONS 35MGREID-PROVIDENT LABS 35MGVITARINE/WEST CHEM 35MGZENITH LABS35MGPHEHZI:HEMALLARD35HGPHENDIMETRAZINE TARTRATETABLET; ORALPLEGIHEAA AYERST LABS/AMHOSTATOBEX35MGAA LEMMON PHARMACAL 35MGSTATOBEX-GAA LENMON PHARMACAL 35HGPHENELZINE SULFATETABLET; ORALNARDILPARKE-DAVIS/W-LPHENINDIONETABLET; ORALHEDULINMERRELL-NATIONALPHENMETRAZINE HYDROCHLORIDEEQ ISMG BASESOMGTABLET; OR.A.LPRELUDINBOEHRINGER INGELHEIM 2SMGTABLET, CONTROLLED RELEASE; ORALPRELUDINBOEHRINGER INGELHEIM SOMG * 7SMGPHENOXYBENZAMINE HYDROCHLORIDECAPSULE; ORALDIBENZYLINESK&FPHENPROCOUHONTABLET; ORALLIQUAMARORGANON/AKZONAIOMG3MG
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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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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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