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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX4AMERXCAH BXOLOGXCSHEPARIN SODIUM, HEPARIN SODIUMAMERXCAH HOSP SUPPLYHALOTHANE, HALOTHANEAMERSHAM/RAOXOCHEMDICOPAC KIT, CYANOCOBALAMINIBRIN, FIBRINOGEN, 1-125SElENOMETHIONINE SE 75, SElENOMETHIONINE, SE-75AMES DIV MILES LABSRADIO-IODINATED (I 125) SERUM ALBUMIN (HUMAN), ALBUMIN,IODINATED, 1-125, SERUMANABOLICBRO~IPHENIRAMINEMALEATE, BROMPHENIRAMINE MALEATECHlORPHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATEDIMENHYDRINATE, DItlENHYDRINATEDIPHENHYDRAMINE HCl, DIPHENHYDRAMINE HYDROCHLORIDEFOLIC ACID, FOLIC ACIDHYDROCORTISONE, HYDROCORTISONEISONIAZID, ISONIAZIDMECLIZINE HCl, MEClIZINE HYDROCHLORIDEtlEPROBAMATE, MEPROBAMATEPHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPROPOXYPHENE COHPOUND 65, ASPIRINPROPOXYPHENE HCl, PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILRESERPINE, RESERPINESODIUM PENTOBARBITAL, PENTOBARBITAL SODIUMSODIUM SECOBARBITAL, SECOBARBITAL SODIUMTRIPELENNAMINE HCl, TRIPElEh~AMINE HYDROCHLORIDEARB ROOKGAHOPHEN, HEXACHLOROPHENEARCUM PH ARMVITAMIN A, VITAMIN AVITAMIN A PALMITATE, VITAMIN A PALMITATEARMnUR PHARMACTHAR, CORTICOTROPINACTHAR GEL-SYNTHETIC, SERACTIDE ACETATEALPHA CHYMAR, CHYtl0TRYPSmCAlCIMAR, CALCITONIN, SALMONDEPHlAR, CYANOCOBALAMINH.P. ACTHAR GEL, CORTICOTROPINHEPRINAR, HEPARIN SODIUMNICOlAR, NIACINTHYROlAR-0.25. lEVOTHYROXHlE SODIUMTHYROlAR-0.5, lEVOTHYROXINE SODIUMARMOUR PHARMTHYROlAR-l, lEVOTHYROXINE SODIUMTHYROlAR-2, lEVOTHYROXINE SODIUMTHYROlAR-3, lEVOTHYROXINE SODIUMTHYROlAR-5, lEVOTHYROXINE SODIUMTHYTROPAR, THYROTROPINTRYPTAR, TRYPSINARMOUR-DIAL/ARMOURDIAL, HEXACHLOROPHENEARHAR-STOHE LABSSOPOR, METHAQUALONEASTRA PHA~MPRODSBRICANYl, TERBUTAlINE SULFATECITANEST, PRIlOCAINE HYDROCHLORIDECITANEST FORTE, EPINEPHRHlEDURANEST, ETIDOCAINE HYDROCHLORIDEDURANEST W/ EPINEPHRINE, EPINEPHRINEXYlOCAINE, lIDOCAINEXYLOCAINE, lIDOCAINE HYDROCHLORIDEXYlOCAINE (VISCOUS), lIDOCAINE HYDROCHLORIDEXYLOCAINE HCl W/ DEXTROSE, DEXTROSEXYLOCAIHE HCl W/ GLUCOSE, DEXTROSEXYlOCAIHE W/ EPINEPHRINE, EPINEPHRINEAYERST LABS/AMHOA.P.l., GONADOTROPIN, CHORIONICANTABUSE, DISULFIRAMATROMID-S, CLOFIBRATEAVlOSUlFON, DAPSONEDIUCARDIN, HYDROFlUMETHIAZIDEESTRADURIN, POlYESTRADIOl PHOSPHATEESTROGENIC SUBSTANCE. ESTRONEFlUOTHANE, HALOTHANEGRISACTIN, GRISEOFULVIN, MICROCRYSTAllINEGRISACTIN ULTRA, GRISEOFULVIN, UlTRAMICROCRYSTAllINEINDERAl, PROPRANOLOL HYDROCHLORIDEIh~ERIDE, HYDROCHLOROTHIAZIDEMYSOlINE, PRIHIDONEPENBRITIN, AMPICIllIN/AMPICILLIN TRIHYDRATEPENERITIN-S. AHPICIllIN SODIUMPEPTAVlON, PENTAGASTRINPHOSPHO lINE IODIDE, ECHOTHIOPHATE IODIDEPlEGINE, PHENDII1ETRAZINE TARTRATEPMB 200. ESTROGENS, CONJUGATEDPMB 400, ESTROGENS, CONJUGATEDPR EtlAR IN, ESTROGENS, CONJUGATEDPROTOP.o\,M CHLORIDE, PRAlIDOXIME CHLORIDETHIOSUlFIl, SUlFAMETHIZOlEVERACIllIN, DIClOXICIllIN SODIUM MONOHYDRATE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX5** B **BAHNER GELATIN PRt!!JSCHLOROTRIANISENE, CHLOROTRIANISENEETHCHLORVYNOL, ETHCHLORVYNOLVITAMIN A PALMITATE, VITAMIN A PALMITATEBARHr:S-HT.HO FHARMSBENOXINATE HCL, BENOXINATE HYDROCHLORIDECYCLOPENTOLATE HCL, CYCLOPENTOLATE HYDROCHLORIDEDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEGAMEt~E, LINDANEPREDNISOLONE SODWM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATEPROPARACAINE HCL, PROPARACAINE HYDROCHLORIDESODIUM SULFACETAMIDE, SULFACETAMIDE SODIUMUNIMIN, PREDNISOLONE SODIUM PHOSPHATEBARR LABSACETAMINOPHEN W/ CODEINE, ACETAMINOPHENAMITRIPTYLINE HCL, AMITRIPTYLINE HYDROCHLORIDEBRO~IPHENIRAMINE MALEATE, BROMPHENIRAMINE MALEATECHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLORPHENIRA~IINEMALEATE, CHLORPHENIRAMINE MALEATECORTISONE ACETATE, CORTISONE ACETATEDEXAMETHASONE, DEXAttETHASONEDIPHENHYDRAMINE HCL, DIPHE~~YDRAMINE HYDROCHLORIDEDIPHENOXYLATE HCL AND ATROPINE SULFATE, ATROPINE SULFATEERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN STEARATE, ERYTHROMYCIN STEARATEHYDRALAZINE HCL, HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE W/ RESERPINE, HYDROCHLOROTHIAZIDEHYDROCORTISONE, HYDROCORTISONEISONIAZID, ISONIAZIDMEPROBAMATE, MEPROBAMATEMETHOCAR8AMOL, METHOCARBAMOLPHENDItIETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPROPOXYPHENE HCL, PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATERESERPINE, RESERPItlESODIU~I SECOBARBITAL, SECOBARBITAL SODIUMSULFISOXAZOLE, SULFISOXAZOLETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETRIAMCINOLONE, TRIAMCINOLONETRIPELENNAMINE HCL, TRIPELE~AMINEHYDROCHLORIDEBARTOR rHAp.!1ACALTESTOSTERONE, TESTOSTERONEBAY LABSDIPHEN, DIPHENHYDRAMINE HYDROCHLORIDESODIUM BUTABARBITAL, BUTABARBITAL SODIUMTHEOPHYLLINE, THEOPHYLLINEBAYLOR LABSORLEX, ACETIC ACID, GLACIALORLEX HC, ACETIC ACID, GLACIALBEECHAM LABSAMINOPHYLLINE, AMINOPHYLLINEAMOXIl, AMOXICILLIN TRIHYDRATEBACTOCILL, OXACILLIN SODIUM MONOHYDRATECELBENIN, METHICILLIN SODIUM MONOHYDRATECHLORPROMAZINE HCL, CHLORPROMAZWE HYDROCHLORIDECLOXAPEN, CLOXACILLIN SODIUM NONOHYDRATEDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEDYCILL, DICLOXICILLIN SODIUM MONOHYDRATEFASTIN, PHENTERMINE HYDROCHLORIDEKLEBCIL, KANAMYCIN SULFATEMENEST, ESTROGENS, ESTERIFIEDNALLPEN, NAFCILLIN SODIUM MONOHYDRATEPHYTONADIONE, PHYTONADIONEPROBENECID, PROBENECIDPROBENECID AND COLCHICINE, COLCHICINEPYOPEN, CARBENICILLIN DISODIUMQUINIDINE SULFATE, QUINIDWE SULFATETICAR, TICARCILLIN DISODIUMTIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDETOTACILLIN, AMPICIllIN/AtIPICILLIN TRIHYDRATETOTACILLIN-N, AMPICILLIN SODIUMTRISEM, TRISULFAPYRIMIDINESBEL-MAR LABSCHLORPHENIRAMINE MALEATE, CHLORPHENIRAHINE MALEATECHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONICDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE seDIUM PHOSPHATEDIPHEt~YDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEHEPARIN SODIUM, HEPARIN SODIUMHYDROCORTISOtfE ACETATE, HYDROCORTISONE ACETATELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDELIDOCAINE HCL W/ EPINEPHRINE, EPINEPHRINEM-PREDROL, METHYLPREDNISOLONE ACETATEPREDNISOLONE ACETATE, PREDNISOLONE ACETATEPROCAINE HCL, PROCAINE HYDROCHLORIDEPROCAINE HCL W/ EPINEPHRINE, EPINEPHRINEPYRIDAMAL 100, CHLORPHENIRAMINE MALEATEPYRIDOXINE HCL. PYRIDOXINE HYDROCHLORIDERUBIVITE, CYANOCOBALAMIN
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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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-,----APPROVED PRESCRIPTION DRUG PR
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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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PRESCRIPTION DRUG PRODUCTS DEEMED A
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