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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX30RICHLYH LABSPREDNxSOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROBENECID AND COLCHICINE, COLCHICINEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPROPANTHELINE BROMIDE, PROPANTHELINE BROMIDEPROPOXYPHENE HCL, PROPOXYPHENE HYDROCHLORIDEPROPOXYPHENE HCL WI A.P.C., ASPIRINPROPYLTHIOURACIL, PROPYLTHIOURACILPYRILAMINE tIALEATE, PYRILAMINE tlALEATEQUINIDINE SULFATE, QUINIDINE SULFATERAUWOLFIA SERPENTINA, RAUWOLFIA SERPENTINARESERPINE, RESERPINESULFA-TRIPLE #2, TRISULFAPYRIMIDINESSULFADIAZINE, SULFADIAZINESULFISOXAZOLE, SULFISOXAZOLETETRACYCLINE HC.L, TETRACYCLINE HYDROCHLORIDETHYROGLOBULIN, THYROGLOBULINTRIAMCINOLONE, TRIAMCINOLONETRICHLORMETHIAZIDE, TRICHLORMETHIAZIDETRIPELENNAMINE HCL, TRIPELENNAMINE HYDROCHLORIDEVITAMIN A, VITAMIN AVITAMIN A, VITAMIN A PALMITATEVITAMIN 0, ERGOCALCIFEROLRIKER LABSI!'MCIRCANOL, DIHYDROERGOCORNINE MESYLATEDIAFEN HCL, DIPHENYLPYRALINE HYDROCHLORIDEDISIPAL, ORPHENADRINE HYDROCHLORIDEDUO-MEDIHALER, ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HCL, ISOPROTERENOL HYDROCHLORIDELIPO-HEPIN, HEPARIN SODIUMMEDIHALER ERGOTAMINE, ERGOTAMINE TARTRATEMEDIHALER-ISO, ISOPROTERENOL SULFATENOR FLEX , ORPHENADRINE CITRATENORGESIC, ASPIRINNORGESIC FORTE, ASPIRINRAU~ILOID, ALSEROXYLONSODIUM VERSENATE, EDETATE DISODIUMTEPANIL, DIETHYLPROPION HYDROCHLORIDETEPANIL TEN-TAB, DIETHYLPROPION HYDROCHLORIDETHEOLAIR, THEOPHYLLINEULO, CHLOPHEDIANOL HYDROCHLORIDEUREX, METHENAMINE HIPPURATEVERILOID, ALKAVERVIRVERSENATE, EDETATE CALCIUM DISODIUMROCHE PRO!)UCTSDALMAt~E, FLURAZEPAM HYDROCHLORIDELIBRITABS, CHLORDIAZEPOXIDELIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDEROERXG/PFIZERANTIMINTH, PYRANTEL PAMOATEANTIVERT, MECLIZINE HYDROCHLORIDEATARAX, HYDROXYZINE HYDROCHLORIDEEMETE-CON. BENZQUINAMIDE HYDROCHLORIDEGEOCILLIN, CARBENICILLIN INDANYL SODIUMGEOPEN, CARBENICILLIN DISODIUMNAVANE, THIOTHIXENENAVANE, THIOTHIXENE HYDROCHLORIDESUSTAIRE, THEOPHYLLINETAO, TROLEANDOMYCINROSS LABS/ABBOTTPEDIAZOLE, ERYTHROMYCIN ETHYLSUCCINATEROtlELL LABSCIN-QUIN, QUINIDINE SULFATECORTENEMA, HYDROCORTISONEDERMACORT, HYDROCORTISONEDEXONE 0.5, DEXAMETHASONEDEXONE 0.75, DEXAMETHASONEDEXOHE 1.5, DEXAMETHASONEDEXOI~E 4, DEXAMETHASONElITHOBID, LITHIUM CARBONATElITHONATE, LITHIUM CARBONATElITHONATE-S, LITHIUM CITRATELITHOTABS, LITHIUM CARBONATEORASONE, PREDNISONEPROCTOCORT, HYDROCORTISONES.A.S.-500, SULFASALAZINE 'VIO-SERPINE, RESERPINERP SCHERERPREDNISONE, PREDNISONE** S **SAHUOZ PHARMSACYLANID, ACETYLDIGITOXINCAFERGOT, CAFFEINECEDILANID-D, DESLANOSIDED.H.E. 45, DIHfDROERGOTAMINE MESYLATEDIAPID, LYPRESSINFIORINAL, ASPIRINHYDERGINE, DIHYDROERGOCORNINE MESYLATEMELLARIL, THIORIDAZINE HYDROCHLORIDEMELLARIL-S, THIORIDAZINE
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX-31** S **SANOOZ FHARMSMESANTOIN, MEPHENYTOINMETHERGINE, METHYLERGONOVINE MALEATEPAMELOR, NORTRIPTYLINE HYDROCHLORIDEPARLODEL, BRONOCRIPTINE MESYLATESANOREX, MAZINDOLSANSERT, METHYSERGIDE MALEATESERENTIL, MESORIDAZINE BESYLATESYNTOCINON, OXYTOCINTORECAN, THIETHYLPERAZINE MALATETORECAN, THIETHYLPERAZINE MALEATESAVAGE/BYK-GVLOEtfALPHA-RUVITE, HYDROXOCOBALAMINDILOR, DYPHYLLINEDILOR-400, DYPHYLLINEDITATE-DS, ESTRADIOL VALERATEGVS, GENTIAN VIOLETNEGATAN, NEGATOLRUVITE. CYANOCOBALAMINZIPAN-25. PROMETHAZINE HYDROCHLORIDEZIPAN-50, PROMETHAZIN~ HYDROCHLORIDESCHERIIiSAKRINOL, ACRISORCINBETAPAR, MEFREDNISONECELESTONE, BETAMETHASONECELESTONE, BETANETHASONE SODIUM PHOSPHATECELESTONE SOLUSPAN, BETANETHASONE ACETATECHLOR-TRINETON. CHLORPHENIRANINE MALEATEDIPROSONE, BETAMETHASONE DIPROPIOI~ATEDISOMER, DEXBROMPHENIRAMINE MALEATEDRIXORAL, DEXBROMFHENIRAMINE MALEATEESTINYL, ETHINYL ESTRADIOLETRAFON A, AMITRIPTYLINE HYDROCHLORIDEETRAFON 2-10, AMITRIPTYLINE HYDROCHLORIDEETRAFON 2-25, AMITRIPTYLINE HYDROCHLORIDEETRAFON-FORTE, AMITRIPTYLINE HYDROCHLORIDEFULVICIN-P/G, GRISEOFULVIN, ULTRAMICROCRYSTALLINEFULVICIN-U/F, GRISEOFULVIN, MICROCRYSTALLINEGARANYCIN, GENTAtlICIN SULFATEGniE-LOTRIMIN, CLOTRINAZOLE·HYPERSTAT,DIAZOXIDELOTRININ, CLOTRINAZOLEMETI-DERN, ALUMINUM CHLORHYDROXY ALLANTIONATENETICORTELONE ACETATE, PREDNISOLONE ACETATEMETICORTEN, PREDNISONEMETRETON, PREDNISOLONE SODIUM PHOSPHATEMIRADON, ANISI~~IONENAQUA, TRICHLORMETHIAZIDESCHERJ:HGNAQUIVAL, RESERPINEOPTIMINE, AZATADINE MALEATEORETON, METHYLTESTOSTERONEORETON, TESTOSTERONEORETON METHYL, METHYLTESTOSTERONEOTOBIONE, HYDROCORTISONE'PERMITIL, FLUPHENAZINE HYDROCHLORIDEPRANTAL, DIPHEMANIL METHYLSULFATEPROGLYCEM, DIAZOXIDERELA, CARISOPRODOLSODIUM SULAMYD, SULFACETAMIDE SODIUMTI~~AL, ACETOPHENAZINE MALEATETREMIN, TRIHEXYPHENIDYL HYDROCHLORIDETRlLAFON, PERPHENAZINEVALISONE, BETAMETHASONE VALERATEVANCERIL, BECLOMETHASONE DIPROPIONATESCHMZD F~ODUCTSCANDEPTIN. CANDICIDINSEARLEALDACTAZIDE, HYDROCHLOROTHIAZIDEALDACTONE, SPIRONOLACTONEBANTHINE, METHANTHELINE BROMIDEDEtruLEN, ETHINYL ESTRADIOLDEtlULEN-FE-28, ETHINYL ESTRADIOLDEMULEN-28, ETHINYL ESTRADIOLENOVID, MESTRANOLENOVID-E, MESTRANOLENOVIO-E 21, tlESTRANOLFLAGYL, METRONIDAZOLELOtIOTIL, ATROPINE SULFATEOVULEN, ETHYNODIOL DIACETATEOVULEN-21, ETHYNOOIOL DIACETATEOVULEN-28, ETHYNODIOL DIACETATEPRO-BANTHINE, PROPANTHELINE BROMIDESEAJ:1LE PHA~MSALIDASE, HYALURONIDASEAMINOPHYLLIN, AMINOPHYLLINEANAVAR, OXANDROLONECU-7, COPPERDRAMAMINE, DIMENHYDRINATENORPACE, DISOPYRAMIDE PHOSPHATETATUM-T, COPPER
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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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