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

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APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX20TIt10PTIC. TIMOLOL MALEATETINDAL. ACETOPHENAZINE MALEATETOFRA~UL, IMIPRAMINE HYDROCHLORIDETOFRANIL-PM, IMIPRAMINE PAMOATETOLBUTAMIDE, TOLBUTAMIDETOLECTIN, TOLMETIN SODIUMTOLECTIN OS, TOLMETIN SODIUMTOLINASE, TOLAZAMIDETOPICORT, DESOXnlETASONETOPICORT LP, DESOXIMETASONETOPICYCLINE, TETRACYCLINE HYDROCHLORIDETOPSYN, FLUOCINONIDETORECAN, THIETHYLPERAZINE MALATETORECAN, THIETHYLPERAZINE MALEATETOTACILLIN, AMPICILLIN/AMPICILLIN TRIHYDRATETOTACILLIN-N, AMPICILLIN SODIUMTRAL, HEXOCYCLIUM METHYLSULFATETRANCOPAL, CHLORMEZANONETRANtIEP, MEPROBAMATETRANSDERM-V, SCOPOLAt1INE HYDROBROMIDETRANXENE, CLORAZEPATE DIPOTASSIUMTRANXENE SD, CLORAZEPATE DIPOTASSIUMTRAVASE, SUTlLAINSTRAVASOL M 3.5% W/ ELECTROLYTE 45, AMINO ACIDSTRAVASOL 10% W/O ELECTROLYTES, AMINO ACIDSTRAVASOL 5.5% W/ ELECTROLYTES, AMINO ACIDSTRAVASOL 5.5% W/O ELECTROLYTES, AMINO ACIDSTRAVASOL 8.5% W/ ELECTROLYTES, AMINO ACIDSTRAVASOL 8.5% W/O ELECTROLYTES, AMINO ACIDSTRAVERT 10% IN PLASTIC CONTAINER, INVERT SUGARTRECATOR-SC, ETHIONAHIDETREMIN, TRIHEXYPHENIDYL HYDROCHLORIDETREST, METHIXENE HYDROCHLORIDETRI-A-MUL, TRISULFAPYRIMIDINESTRI-A-TAB, TRISULFAPYRIMIDINESTRIACET, TRIAMCINOLONE ACETONIDETRIAtICINOLONE, TRIAMCINOLONETRIAMCINOLONE ACETONIDE, TR~AMCINOLONE ACETONIDETRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATETRIAVIL 2-10, AMITRIPTYLINE HYDROCHLORIDETRIAVIL 2-25, AMITRIPTYLINE HYDROCHLORIDETRIAVIL 4-10, AMITRIPTYLINE HYDROCHLORIDETRIAVIL 4-25, AMITRIPTYLINE HYDROCHLORIDETRIAVIL 4-50, AMITRIPTYLINE HYDROCHLORIDETRICHLORtlAS, TRICHLORMETHIAZIDETRICHLORMETHIAZIDE, TRICHLORMETHIAZIDETRICHLORMETHIAZIDE W/ RESERPINE, RESERPINETRICLOS, TRICLOFOSTRIDESILON, ACETIC ACID, GLACIAL- TRIDESILON, DESONIDETRIDIONE, TRHIETHADIONETRIHEXYPHENIDYL HCL, TRIHEXYPHENIDYL HYDROCHLORIDETRILAFON, PERPHENAZINETRIMOX, AMOXICILLIN TRIHYDRATETRIMPEX, TRIHETHOPRIMTRIOLEIN I 131, TRIOLEIN, 1-131TRIPELENN.MIINE HCL, TRIPELENNAMINE HYDROCHLORIDETRIPLE SULFA, SULFABENZAHIDETRIPLE SULFA, TRISULFAPYRHIIDINESTRIPLE SULFA #2, TRISULFAPYRIMIDINESTRIPLE SULFAS, TRISULFAPYRIMIDINESTRIPLE SULFOID, TRISULFAPYRIMIDINESTRIPROLIDINE HCL, TRIPROLIDINE HYDROCHLORIDETRISEM, TRISULFAPYRHIIDINESTRISORALEN, TRIOXSALENTRISUREID, TRISULFAPYRIMIDINESTROBICIN, SPECTINOMYCIN HYDROCHLORIDETRYPTAR, TRYPSINTUBOCURARINE CHLORIDE, TUBOCURARINE CHLORIDETUCKS HC, HYDROCORTISONE ACETATETYBATRAN, TYBAMATETYLENOL W/ CODEINE, ACETAMINOPHENTYLOSTERONE, DIETHYLSTILBESTROLTYLOX, ACETAMINOPHENTYZINE, TETRAHYDROZOLINE HYDROCHLORIDE** U **ULO, CHLOPHEDIANOL HYDROCHLORIDEULTRA-TECHNEKOW FM, TECHNETIUM, TC-99M GENERATOR/SODIUMPERTECHNETATE, TC-99MUNIGESIC, PROPOXYPHENE HYDROCHLORIDEUNHIIH, PREDNISOLONE SODIUM PHOSPHATEUNIPEN, NAFCILLIN SODIUM tlONOHYDRATEW~IPRES, HYDRALAZINE HYDROCHLORIDEUNITENSEN, CRYPTENAHItlE ACETATESUNITENSEN, CRYPTENAt1INE TANNATESURACIL MUSTARD, URACIL MUSTARDUREAPHIL, UREAURECHOLINE, BETHANECHOL CHLORIDEUREVERT, INVERT SUGARUREX, METHENAMINE HIPPURATEURISPAS, FLAVOXATE HYDROCHLORIDEUTIBID, OXOLINIC ACIDUTICILLIN VK, PENICILLIN V POTASSIUMUTICORT, BETAHETHASONE BENZOATEUTIHOX, AHOXICILLIN TRIHYDRATE** V lH
oAPPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX-21VALISONE, BETAMETHASONE VALERATEVALIUtl, DIAZEPAMVALMID, ETHINAtlATEVALPIN 50, ANISOTROPINE METHYLBROMIDEVANCERIL, BECLmlETHASONE DIPROPIONATEVANCOCIN HCL, VANCONYCIN HYDROCHLORIDEVANOBID, CANDICIDINVANSIL, OXAf1NIQUINEVAPO-ISO, ISOPROTERENOL HYDROCHLORIDEVASCORAY, IOTHALAMATE MEGLUMINEVASOCON. NAPHAZOLINE HYDROCHLORIDEVASOXYL, METHOXAMINE HYDROCHLORIDEVEETIDS '125', PENICILLIN V POTASSIUMVEETIDS '250', PENICILLIN V POTASSIUMVEETIDS '500', PENICILLIN V POTASSIUMVEINAMINE 8/., AMINO ACIDSVELBAN, VINBLASTINE SULFATEVELOSEF, CEPHRADINEVELTANE, BRotlPHENIRAMINE MALEATEVENTAIRE, PROTOKYLOL HYDROCHLORIDEVERACILLIN, DICLOXICILLIN SODIUM MONOHYDRATEVERCYTE, PIPOBROMANVERILOID, ALKAVERVIRVERtlIDOL, PIPERAZINE CITRATEVERMOX, MEBENDAZOLEVERSAPEN, HETACILLINVERSAPEN-K, HETACILLIN POTASSIUMVERSENATE, EDETATE CALCIUM DISODIUMVERSTRAN, PRAZEPAMVESPRIN, TRIFLUPROMAZINE HYDROCHLORIDEVESPRIN HIGH POTENCY, TRIFLUPROMAZINEVI-DOtl-A, VITAtlIN A PALMITATEVI-n~EL, CYANOCOBALAMINVIBISONE, CYANOCOBALAMINVIBRA-TABS, DOXYCYCLINE HYCLATEVIBRAMYCIN, DOXYCYCLINE CALCIUMVIBRAMYCIN, DOXYCYCLINE HYCLATEVIBRAMYCIN, DOXYCYCLINE MONOHYDRATEVICODIN, ACETAMINOPHENVIO-SERPINE, RESERPINEVIOCIN SULFATE, VIOMYCIN SULFATEVIRA-A, VIDARABINEVIRA-A, VIDARABINE MONOHYDRATEVIRAC REX, UNDECOYLIUM CHLORIDEVIRILON, METHYLTESTOSTERONEVIROPTIC, TRIFLURIDINEVISTARIL, HYDROXYZINE HYDROCHLORIDEVISTARIL, HYDROXYZINE PAtlOATEVITAMIN A, VITAMIN AVITAMIN A, VITAMIN A PALMITATEVITAMIN A PALMITATE, VITAMIN A PALMITATEVITAMIN A SOLUBILIZED, VITAMIN A PALMITATEVITAMIN 0, ERGOCALCIFEROLVIVACTIL, PROTRIPTYLINE HYDROCHLORIDEVONTROL, DIPHENIDOL HYDROCHLORIDEVCRANIL, CLORTERMINE HYDROCHLORIDEVOSOL, ACETIC ACID, GLACIALVOSOL HC, ACETIC ACID, GLACIAL** 14 **WAMPOCAP, NIACINWESCOHEX, HEXACHLOROPHENEWESTADONE, METHADONE HYDROCHLORIDEWESTASEPT, HEXACHLOROPHENEWESTCORT, HYDROCORTISONE VALERATEWOLFINA, RAUWOLFIA SERPENTINAWYAMINE SULFATE, MEPHENTERHINE SULFATEWYAMYCIN E, ERYTHROMYCIN ETHYLSUCCINATEWYAMYCIN S, ERYTHROMYCIN STEARATEWYCILLIN, PENICILLIN G PROCAINEWYDASE, HYALURONIDASEWYGESIC, ACETAMINOPHENWYMOX, AMOXICILLIN TRIHYDRATE** X **XENEISOL, XENON, XE-133XENON XE 133, XENON, XE-133XENON XE 133-V.S.S., XENON, XE-133XYLO-PFAN, XYLOSE, D-XYLOCAINE, LIDOCAINEXYLOCAINE, LIDOCAINE HYDROCHLORIDEXYLOCAINE (VISCOUS), LIDOCAINE HYDROCH LORIDEXYLOCAINE HCL WI DEXTROSE, DEXTROSEXYLOCAINE HCL WI GLUCOSE, DEXTROSEXYLOCAINE WI EPINEPHRINE, EPINEPHRINE** Y **YTTERBIUM YB 169 DTPA, PENETATE CALCIUM TRISODIUM, YB-169** Z **ZARONTIN, ETHOSUXIMIDEZAROXOLYN, METOLAZOHEZIBA-RX, BACITRACIN ZINCZIPAN-25, PROMETHAZINE HYDROCHLORIDEZIPAN-50, PROMETHAZINE HYDROCHLORIDEZOLYSE, CHvtlOTRYPSINZYLOPRIM, ALLOPURINOL
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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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PRESCRIPTION DRUG PRODUCTS DEEMED A
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