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

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APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX4CHLOROTHIAZIDE, CHLOROTHIAZIDECHLOROTHIAZIDE WI RESERPINE, CHLOROTHIAZIDECHLOROTRIANISENE, CHLOROTRIANISENECHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECHLORPROMAZINE HCL, CHLORPROMAZINE HYDROCHLORIDECHLORPROPAMIDE, CHLORPROPAMIDECHOLEBRINE, IOCETAMIC ACIDCHOLEDYL, OXTRIPHYLLINECHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINECHOLOGRAFIN SODIUM, IODIPAMIDE SODIUMCHOLOXIN, DEXTROTHYROXINE SODIUMCHOR:j:OtUC GONADOTROPIN, GONADOTROPIN, CHORIONICCHROMALBIN, ALBUMIN, CHROMATED, CR-51, SERUMCHROMITOPE SODIUM, SODIUM CHROMATE, CR-51CHRONULAC, LACTULOSECIN-QUIN, QUINIDINE SULFATECINNASIL, RESCINNAMINECINOBAC, CINOXACINCINTICHEM TECHNETIUM 99M DPTA, TECHNETIUM, TC-99M, PENTETATE KITCINTICHEM TECHNETIUM 99M GENERATOR, TECHNETIUM, TC-99MGENERATORISODIUM PERTECHNETATE, TC-99MCINTICHEM TECHNETIUM 99M HEDSPA, TECHNETIUM, TC-99M, ETIDRONATEKITCINTICHEM TECHNETIUM 99~ HSA, TECHNETIUM, TC-99M, ALBUMIN KITCINTICHEM TECHNETIUM 99M MAA, TECHNETIUM, TC-99M, ALBUMINAGGREGATED KITCINTICHEM TECHNETIUM 99M TSC,·TECHNETIUM, TC-99M, SULFURCOLLOID KITCIRCANOL, DIHYDROERGOCORNINE MESYLATECITANEST, PRILOCAINE HYDR0:HLORIDECITANEST FORTE, EPINEPHRINECLEOCIN, CLINDAMYCIN HYDROCHLORIDE HYDRATECLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDECLEOCIN, CLI~rnAMYCIN PHOSPHATECLINORIL, SULINDACCLISTIN, CARBINOXAMINE MALEATECLODERM, CLOCORTOLONE PIVALATECLOMID, CLOMIPHENE CITRATECLONOPIN, CLONAZEPAMCLOXACILLIN SODIUM, CLOXACILLIN SODIUM MONOHYDRATECLOXAPEN, CLOXACILLIN SODIUM MONOHYDRATECOBAVITE, CY A~mCOBA LAMINCOOAP, ACETAMINOPHENCODEINE PHOSPHATE AND ACETAMINOPHEN, ACETAMINOPHENCODEINE, ASPIRIN, APAP FORtlULA NO.2, ACETAMINOPHENCODEINE, ASPIRIN, APAP FORMULA NO.3, ACETAMINOPHENCODEINE, ASPIRIN, APAP FORMULA NO.4, ACETAMINOPHENCOGENTIN, BENZTROPINE MESYLATECOL-PROBENECID, COLCHICINECOLBENEMID, COLCHICINECOLESTID, COLESTIPOL HYDROCHLORIDECOLY-MYCIN M, COLISTIMETHATE SODIUMCOLY-MYCIN S, COLISTIN SULFATECOtIBIPRES, CHLORTHALIDONECOMOX, AMOXICILLIN TRIHYDRATECOMPAZINE, PROCHLORPERAZINECOMPAZINE, PROCHLORPERAZINE EDISYLATECOMPAZINE, PROCHLORPERAZINE MALEATECONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDCONRAY, IOTHALAMATE MEGLUMINECO~mAY-30, IOTHALAMATE MEGLUMINECONRAY-325, IOTHALAMATE SODIUMCOtmAY-400, IOTHALAMATE SODIUMCOPPER T, COPPERCORDRAN, FLURAtIDRENOLIDECORDRAN SP, FLURANDRENOLIDECORGARD, NADOLOLCORT-DOME, HYDROCORTISONECORTALONE, PREDNISOLONECORTANE, BROMPHENIRAMINE MALEATECORTEF, HYDROCORTISONECORTEF, HYDROCORTISONE CYPIONATECORTEF ACETATE, HYDROCORTISONE ACETATECORTENEMA, HYDROCORTISONECORTICOTROPIN, CORTICOTROPINCORTISONE ACETATE, CORTISONE ACETATECORTISPORIN, HYDROCORTISONECORTONE, CORTISONE ACETATECORTRIL, HYDROCORTISONECORTRIL, HYDROCORTISONE ACETATECORTROPHIN-ZINC, CORTICOTROPINCORTROSYN, COSYNTROPINCOSMEGEN, DACTINOMYCINCOUtIADIN, WARFARIN SODIUMCRESCORMON, SOMATROPINCRYSTODIGIN, DIGITOXINCU-7, COPPERCUPRIMINE, PENICILLAMINECURRETAB, MEDROXYPROGESTERONE ACETATECYANOCOBALAMIN, CYANOCOBALAMINCYANOCOBALAMIN CO 57, CYANOCOBALAMIN, CO-57CYCLAINE, HEXYlCAINE HYDROCHLORIDECYCLAPEN, CYCLACILLINCYCLOCORT, AMCINONIDECYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDECYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDECYCLOPAR, TETRACYCLINE HYDROCHLORIDECYCLOPENTOLATE HCL, CYCLOPENTOLATE HYDROCHLORIDECYLERT, PEMOLINECYPROHEPTADINE HCL, CYPROHEPTADINE HYDROCHLORIDECYSTO-CONRAY, IOTHALAMATE MEGLUMINECYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
APPROVED PRESCRIPTION DRUG PRODUCTS·TRADE NAME INDEX5CYSTOGRAFIN, DIATRIZOATE MEGLUMINECYTAL, MANNITOLCYTELLIN, SITOSTEROLCYTotlEL, LIOTHYRONINE SODIUMCYTOSAR-U, CYTARABINECYTOXAN, CYCLOPHOSPHAMIDE** D **D.H. E. 45, DIHYDROERGOTAtlINE MESYLATEDA-I0, DEXTROAMPHETAMINE SULFATEDA-5, DEXTROAMPHETAMINE SULFATEDALMANE, FLURAZEPAM HYDROCHLORIDEDANOCRH1E, DANAZOLDANTRIUM,'DANTROLENE SODIUMDAPSONE, DAPSONEDARANIDE, DICHLORPHENAMIDEDARAPRIM, PYRItlETHANINEDARBID, ISOPROPAMIDE IODIDEDARICON, OXYPHENCYCLIMINE HYDROCHLORIDEDARVOCET-N 100, ACETAMINOPHENDARVOCET-N 50, ACETAMINOPHENDARVON, PROPOXYPHENE HYDROCHLORIDEDARVON COMPOUND, ASPIRINDARVON COMPOUND 65, ASPIRINDAR VON WI ASA, ASPIRINDARVON-N, PROPOXYPHENE NAPSYLATEDARVON-N WI ASA, ASPIRINDDAVP, DESMOPRESSINDEAPRIL-ST, DIHYDROERGOCORNINE MESYLATEDECADERM, DEXAMETHASONEDECADRON, DEXAMETHASONEDECADRON, DEXAMETHASONE SODIUM PHOSPHATEDECADRON WI XYLOCAINE, DEXAMETHASONE SODIUM PHOSPHATEDECADRON-LA,'" DEXAMETHASONE ACETATEDECAPRYN, DOXYLAMINE SUCCINATEDECASPRAY, DEXAMETHASONEDECLotlYCIN, DEMECLOCYCLINE HYDROCHLORIDEDEL-VI-A, VITAtUN A PALMITATEDELACORT, HYDROCORTISONEDELADUMONE, ESTRADIOL VALERATEDELADUMONE OB, ESTRADIOL VALERATEDELALUTIN, HYDROXYFROGESTERONE CAPROATEDELATESTRYL, TESTOSTERONE ENANTHATEDELAXIN, METHOCARBAMOLDELCOBESE, AMPHETAMINE ADIPATEDELESTROGEN, ESTRADIOL VALERATEDELTA-CORTEF, PRED~lISOLONEDELTA-DOME, PREDNISONEDELTALIN, ERGOCALCIFEROLDELTASONE, PREDNISONEDEMEROL, MEPERIDINE HYDROCHLORIDEDEMI-REGROTON, CHLORTHALIDONEDEMSER, tlETYROSINEDEMULEN, ETHINYL ESTRADIOLDEMULEN-FE-28, ETHINYL ESTRADIOLDEMULEN-28, ETHINYL ESTRADIOLDENDRID, IDOXURIDINEDEPAKENE, VALPROATE SODIUMDEPAKENE, VALPROIC ACIDDEPEN 250, PENICILLAI1INEDEPINAR, CYANOCOBALAMINDEPO-ESTRADIOL, ESTRADIOL CYPIONATEDEPO-MEDROL, METHYLPREDNISOLONE ACETATEDEPO-PROVERA, MEDROXYPROGESTERONE ACETATEDEPO-TESTADIOL, ESTRADIOL CYPIONATEDEPO-TESTOSTERONE, TESTOSTERONE CYPIONATEDERM-A-CAPS, VITAMIN A PALMITATEDERMACORT, HYDROCORTISONEDESFERAL MESYLATE, DEFEROXAMINE MESYLATEDESOXYN, METHAMPHETAMII~E HYDROCHLORIDEDEXAMETHASONE, DEXAMETHASONEDEXAMETHASONE ACETATE, DEXAMETHASONE ACETATEDEXAt1ETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEDEXAMPEX, DEXTROAMPHETAMINE SULFATEDEXEDRINE, DEXTROAMPHETAMINE SULFATEDEXONE 0.5, DEXAMETHASONEDEXONE 0.75, DEXAMETHASONEDEXot~E 1.5, DEXAMETHASONEDEXONE 4, DEXAMETHASONEDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATEDEXTROSE lOX AND SODIUM CHLORIDE 0.270 IN PLASTIC CONTAINER,DEXTROSEDEXTROSE lOX AND SODIUM CHLORIDE 0.4570 IN PLASTIC CONTAINER,DEXTROSEDEXTROSE lOX AND SODIUM CHLORIDE 0.970 IN PLASTIC CONTAINER,DEXTROSEDEXTROSE lOX IN PLASTIC CONTAINER, DEXTROSEDEXTROSE lOX IN WATER IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 2.570 AND SODIUM CHLORIDE 0.457. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 2.57. AND SODIUM CHLORIDE 0.97. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 2.57. IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 207. IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 3.37. AND SODIUM CHLORIDE 0.370 IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 307. IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 407. IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 57. AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 57. AND POTASSIUM CHLORIDE 0.0757. IN PLASTIC CONTAINER,DEXTROSE
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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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PRESCRIPTION DRUG PRODUCTS DEEMED A
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