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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX22MD PHARMAMITRIPTYLINE HCL, AMITRIPTYLINE HYDROCHLORIDEDI-ATRO, ATROPINE SULFATEDIETHYLPROPION HCL, DIETHYLPROPION HYDROCHLORIDEGLUTETHIMIDE, GLUTETHIMIDEMETHY"LPHENIDATE HCL, METHYLPHENIDATE HYDROCHLORIDEMEAD J(l~HSCHLABSOVCON-3S, ETHINYL ESTRADIOLMEAD JOHtISr.H/BMCYTOXAN, CYCLOPHOSPHAMIDEDEAPRIL-ST, DIHYDROERGOCORNINE MESYLATEDURICEF, CEFADROXIL MONOHYDRATEESTRACE, ESTRADIOLGYNOREST, DYDROGESTERONEKLOTRIX, POTASSIUM CHLO~IDEMEGACE, MEGESTROL ACETATEtlUCOMYST, ACETYLCYSTEWEMUCOMYST WI ISOPROTERENOL, ACETYLCYSTEINEOVCON-3S, ETHINYL ESTRADIOLOVCON-SO, ETHINYL ESTRADIOLQUESTRAN, CHOLESTYRAMINEMEO!-PHYS!CSLUNGAGGREGATE REAGENT, TECHNETIUM, TC-99M, ALBUMIN AGGREGATEDKITMPI KRYPTON 81M GAS GENERATOR, KRYPTON, KR-81MNPI STANNOUS DIPHOSPHONATE, TECHNETIUM, TC-99M, ETIDRONATE KITNEOSCAN, GALLIUM CITRATE, GA-67SODIUM IODIDE I 123, SODIUM IODIDE, 1-123SODIUM PERTECHNETATE TC 99M, SODIUM PERTECHNETATE, TC-99MTC 99M-LUNGAGGREGATE, TECHNETIUM, TC-99H, ALBUMIN AGGREGATEDTECHNETIUM TC 99H SULFUR COLLOID, TECHNETIUM, TC-99M, SULFURCOLLOIDXENON XE 133-V.S.S •• XENON, XE-133MERCK SHARP & OeHMEALDOCLOR-lS0, CHLOROTHIAZIDEALDOCLOR-2S0, CHLOROTHIAZIDEALDOHET, METHYLDOPAALDotlET, METHYLDOPATE HYDROCHLORIDEALDORIL D30, HYDROCHLOROTHIAZIDEALDORIL DSO, HYDROCHLOROTHIAZIDEALDORIL 15, HYDROCHLOROTHIAZIDEALDORIL 2S, HYDROC~ILOROTHIAZIDEALPHAREDISOL, HYDROXOCOBALAMINA~lINOHIPPURATESODIUM, AMINOHIPPURATE SODIUMAQUAMEPHYTON, PHYTONADIONEARAMINE, METARAMINOL BITARTRATEBENEMID, PROBENECIDCLINORIL, SULINDACMERCK SHARP & DOHMECOGENTIN, BENZTROPINE MESYLATECOLBENEMID, COLCHICINECORTONE, CORTISONE ACETATECOSMEGEN, DACTINOMYCINCUPRIMINE, PENICILLAMINECYCLAINE, HEXYLCAINE HYDROCHLORIDEDARANIDE. DICHLORPHENAMIDEDECADERM. DEXAMETHASONEDECADRON,DEXAMETHASONEDECADRON. DEXAMETHASONE SODIUM PHOSPHATEDECADRON WI XYLOCAINE. DEXAMETHASONE SODIUM PHOSPHATEDECADRON-LA; DEXAMETHASONE ACETATEDECASPRAY, DEXAMETHASONEDEHSER, METYROSINEDIUPRES-250, CHLOROTHIAZIDEDIUPRES-SOO, CHLOROTHIAZIDEDIURIL, CHLOROTHIAZIDEDIURIL, CHLOROTHIAZIDE SODIUMEDECRIN, ETHACRYNATE SODIUMEDECRIN, ETHACRYNIC ACIDELAVIL, AMITRIPTYLINE HYDROCHLORIDEFLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDEFLOROPRYL, ISOFLUROPHATEHUMORSOL, DEMECARIUM BROMIDEHYDELTRA TBA, PREDNISOLONE .TEBUTATEHYDELTRASOL, PREDNISOLONE SODIUM PHOSPHATEHYDROCORTONE, HYDROCORTISONEHYDROCORTONE, HYDROCORTISONE ACETATEHYDROCORTONE, HYDROCORTISONE SODIUM PHOSPHATEHYDRODIURIL, HYDROCHLOROTHIAZIDEHYDROPRES-2S, HYDROCHLOROTHIAZIDEHYDROPRES-SO, HYDROCHLOROTHIAZIDEINDOCIN, INDOMETHACININVERSWE HCL, HECAMYLAMINE HYDROCHLORIDELERITINE. ANILERIDINE HYDROCHLORIDELERITINE, ANILERIDINE PHOSPHATELODOSYN, CARBIDOPAMANNITOL, ~IANNITOLMEFOXW, CEFOXITIN SODIUMMEPHYTON, PHYTmlADIONEMINTEZOL, THIABENDAZOLEMUSTARGEN, MECHLORETHAMINE HYDROCHLORIDEPERIACTIN, CYPROHEPTADINE HYDROCHLORIDEREDISOL, CYANOCOBALAMINSINEMET, CARBIDOPATECHNESCAN MOP KIT, TECHNETIUM, TC-99M, MEDRONATE KITTU10PTIC, TIMOLOL MALEATETRIAVIL 2-10, AMITRIPTYLINE HYDROCHLORIDETRIAVIL 2-2S, AMITRIPTYLINE HYDROCHLORIDETRIAVIL 4-10, AMITRIPTYLINE HYDROCHLORIDETRIAVIL 4-2S, AMITRIPTYLINE HYDROCHLORIDE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX23MEPCK ~HA~P ~ DOHNeTRIAVIL 4-50, AMITRIPTYLINE HYDROCHLORIDEURECHOLINE, BETHANECHOL CHLORIDEVIVACTIL, PROTRIPTYLINE HYDROCHLORIDEMER!'CO!l :tWJHSTRIESDELACORT, HYDROCORTISONEHF-~RE'-L-HAT!O~IALBENDECTIN, DOXYlAMINE SUCCINATECANTIL, MEPENZOLATE BROMIDECEPHULAC, l/'.CTULOSECHRONULAC, LACTULOSECLOMID, CLOMIPHENE CITRATECYANOCOBALAMIN, CYANOCOBALAMINDECAPRYN, DOXYLAMINE SUCCINATEDV, DIENESTROLHEDULIN, PIiENINDIONEHIPREX, ~IETHENAHWE HIPFURATEHYDROXYSTILBAMIDINE ISETHIONATE, HYDROXYSTILBAMIDINEISETHlotlA TEHIFERON, IRON DEXTRAN COMPLEXMEH.HYDRIN, TRICHLORMETHIAZIDEMETATENSIN 2, RESERPINEHETATENSIN 4, RESERPINENICALEX, ALUMINUM NICOTINATENORPRAMIN, DESIPRAMINE HYDROCHLORIDETACE, CHLOROTRIANISENETENUATE, DIETHYlPROPION HYDROCHLORIDETRICLOS, TRICLOFOSVANOBID, CANDICIDINM::ss:r:tm ~tl·"mH\Cl\LEQUIPIN, HOMATROPINE METHYLBROMIDEHOHAPIN-IO, HOMATROPINE METHYLBROHIDEHOMAPIN-5, HOMATROPINE METHYLBROMIDEHI< LIIRSA~IFHICOL,CHLORAMPHENICOLBAX, DIPHENHYDRAtlINE HYDROCHLORIDECHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDEFOLIC ACID, FOLIC ACIDHYDROCORTISONE, HYDROCORTISONEISONIAZID, ISONIAZIDKESSO-GESIC, PROPOXYPHENE HYDROCHLORIDEMEPROBAI·IATE, NEPROBAMATENIACIN, NIACINOXY-KESSO-TETRA, OXYTETRACYCLINE HYDROCHLORIDEPREDNISOLONE, PREDNISOLONEPR~DNISONE, PREDNISONERESERPINE, RESERPINESOSOL, SULFISOXAZOLEHK LABSTETRACYCLINE, TETRACYCLINETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDEVITAMIN A, VITAMIN A PALMITATEM~I!1ASTBUTABARBITAL SODIUM, BUTABARBITAL SODIUMDEXTROANPHETAI'1INE SULFATE, DEXTROAMPHETAMINE SULFATEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEMEPROBAMATE, MEFROBAMATEONA MAST, FHENTERMINE HYDROCHLORIDEPHENAZIHE, PHENDIMETRAZINE TARTRATETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETRICHLORMAS, TRICHLORMETHIAZIDEMaO~E K!~K LABSHYSERP, RAUWOLFIA SERPENTINAMYLAH PHARHSAMITRIPTYLINE HCL, AMITRIPTYLINE HYDROCHLORIDEAMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATECHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLOROTHIAZIDE, CHLOROTHIAZIDECHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECYPROHEPTADINE HCL, CYPROHEPTADINE HYDROCHLORIDEDEXAMETHASONE, DEXAMETHASONEDIPHENOXYlATE HCL WI ATROPItlE SULFATE, ATROPINE SULFATEERYTHRotlYCIN STEARATE, ERYTHROMYCIN STEARATEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEMEPROBAMATE, MEPROBAMATEMETHOCARBAMOL, METHOCARBAMOLNIACIN, NIACINPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPENICILLIN V POTASSIUM, PENICILLIN V POTASSIUMPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROBENECID, PROBENECIDPROPANTHELINE BROMIDE, PROPANTHELINE BROMIDEPROPOXYPHENE HCL, PROPOXYPHENE HYDROCHLORIDEPROPOXYPHENE HCL 101/ A.P.C., ASPIRINPROPOXYPHENE HCL 101/ APAP, ACETAMItmPHENPROPYLTHIOL~ACIL, PROPYLTHIOURACILRESERPINE, RESERPINESPIRONOLACTONE-HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESULFISOXAZOLE, SULFISOXAZOLETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETOLBUTAMIDE, TOLBUTAMIDETRIAMCINOLONE, TRIAMCINOLONE
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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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------"".,APPROVED PRESCRIPTION DRU
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