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

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APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX18SODIUM AMINOSALICYLATE, SODIUM AMINOSALICYLATESODIUM SUTASARBITAL, BUTABARBITAL SODIUMSODIUM CHLORIDE, SODIUM CHLORIDESODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM CHLORIDE 0.457. IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM CHLORIDE 0.457. IN WATER IN PLASTIC CONTAINER, SODIUMCHLORIDESODIUM CHLORIDE 0.97. & POTASSIUM CHLORIDE 0.0757. IN PLASTICCONTAINER, POTASSIUM CHLORIDESODIUM CHLORIDE 0.9/. & POTASSIUM CHLORIDE 0.157. IN PLASTICCONTAINER, POTASSIUM CHLORIDESODIUM CHLORIDE 0.97. & POTASSIUM CHLORIDE 0.2247. IN PLASTICCONTAINER, POTASSIUM CHLORIDESODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTICCONTAINER, POTASSIUM CHLORIDESODIUM CHLORIDE 0.97. IN PLASTIC CONTAINER, SODIUM CHLORIDESODIUM CHROMATE CR 51, SODIUM CHROMATE, CR-51SODIUM HEPARIN, HEPARIN SODIUMSODIUM IODIDE I 123, SODIUM IODIDE, 1-123SODIUM IODIDE 1.125, SODIUM IODIDE, 1-125SODIUM IODIDE I 131, SODIUM IODIDE, 1-131SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATESODIUM P.A.S., SODIUM AMINOSALICYLATESODIUM PENTOBARBITAL, PENTOBARBITAL SODIUMSODIUM PERTECHNETATE TC 99M, SODIUM PERTECHNETATE, TC-99MSODIUM PHOSPHATE P 32, SODIUM PHOSPHATE, P-32SODIUM POLYPHOSPHATE-TIN KIT, TECHNETIUM, TC-99M, POLYPHOSPHATEKITSODIUM ROSE BENGAL I 131, SODIUM ROSE BENGAL, 1-131SODIUM SECOBARBITAL, SECOBARBITAL SODIUMSODIUM SUCCINATE, SODIUM SUCCINATE HEXAHYDRATESODIUM SULAMYD, SULFACETAmDE SODIUMSODIUM SULFACETAMIDE, SULFACETAMIDE SODIUMSODIUM VERSENATE, EDETATE DISODIUMSOLATENE, CARDTENE, BETASOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATESOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATESOLU-PRED, PREDNISOLONE SODIUM PHOSPHATESOLVISYN A, VITAMIN A PALMITATESOMA, CARISOPRODOLSOMA COMPOUND, CAFFEINESO~IA COMPOUND WI CODEINE, CAFFEINESotIOPHYLLIN, AMINOPHYlLINESONAZINE, CHLORPROMAZINE HYDROCHLORIDESONILYN, SULFACHLORPYRIDAZINESOPOR, METHAQUALONESORBITOL 3.37. IN PLASTIC CONTAINER, SORBITOLSORBITOL 3% IN PLASTIC CONTAINER, SORBITOLSORBITOL-MANNITOL, MANNITOLSORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOLSOSOL, SULFISOXAZOLE "SOTRADECOL, SODIUM TETRADECYL SULFATESOY-DOME, HEXACHLOROPHENESPARINE, PROMAZINE HYDROCHLORIDESPIRONOLACTONE-HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESPIROt-iOLACTONE, SPIRONOLACTONESPIRONOLACTONE WI HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESTADOL, BUTORPHANOL TARTRATESTANOZIDE, ISONIAZIDSTANSIN, SULFISOXAZOLESTAPHCILLIN, METHICILLIN SODIUM MONOHYDRATESTATOBEX, PHENDIMETRAZINE TARTRATESTATOBEX-G, PHENDIMETRAZINE TARTRATESTATROL, NEOMYCIN SULFATESTELAZINE, TRIFLUOPERAZINE HYDROCHLORIDESTERANE, PREDNISOLONESTERANE, PREDNISOLONE ACETATESTERILE UREA, UREASTERILE WATER, WATER FOR IRRIGATIONSTERILE WATER IN PLASTIC CONTAINER, WATER FOR IRRIGATIONSTERILE WATER IN PLASTIC CONTAINER, WATER, FOR INJECTIONSTILBESTROL, DIETHYLSTILBESTROLSTILPHOSTROL, DIETHYLSTILBESTROL DIPHOSPHATESTOXIL, IDOXURIDINESTREPTOMYCIN SULFATE, STREPTOMYCIN SULFATESUBLIMAZE, FENTANYL CITRATESUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDESUCOSTRIN, SUCCINYLCHOLIt-iE CHLORIDESUDAFED, PSEUDOEPHEDRINE HYDROCHLORIDESULF-I0, SULFACETAMIDE SODIUMSULFA-TRIPLE #2, TRISULFAPYRIMIDINESSULFABID, SULFAPHENAZOLESULFACEL-15, SULFACETAMIDE SODIUMSULFACETAmDE SODIUM, SULFACETAMIDE SODIUMSULFADIAZINE, SULFADIAZINESULFADIAZINE SODIUM, SULFADIAZINE SODIUMSULFALAR, SULFISOXAZOLESULFALOID, TRISULFAPYRIMIDINESSULFAMETHOXAZOLE, SULFAMETHOXAZOLESULFAMYLON, MAFENIDE ACETATESULFAPYRIDINE, SULFAPYRIDINESULFASALAZINE, SULFASALAZINESULFISOXAZOLE, SULFISOXAZOLESULFONAMIDES DUPLEX, SULFADIAZINESULFOSE, TRISULFAPYRIMIDINES.SULFUR COLLOID KIT, TECHNETIUM, TC-99M, SULFUR COLLOID KITSULLA, SULFAMETERSULSOXIN, SULFISOXAZOLESULTRIN, SULFABENZAMIDESUMYCIN, TETRACYCLINESUMYCIN, TETRACYCLINE HYDROCHLORIDESUPERCIDIN, ISONIAZID$:'~~)ti'
APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX19SURITAL, THIAMYLAL SODIUMSURHONTIL, TRIMIPRAMINE MALEATESUS-PHRINE, EPINEPHRINESUSTAIRE, THEOPHYLLINESYMMETREL, AMANTADINE HYDROCHLORIDESYNALAR, FLUOCINOLONE ACETONIDESYNALAR-HP, FLUOCINOLONE ACETONIDESYNCURINE, DECAMETHONIUM BROtlIDESYNEMOL, FLUOCINOLONE ACETONIDESYNKAYVITE, MENADIOL SODIUM DIPHOSPHATESYNOPHYLATE, THEOPHYLLINE SODIUM GLYCINATESYNTOCINON, OXYTOCINSYTOBEX, CYANOCOBALAMIN** T **TACARYL, METHDILAZINE HYDROCHLORIDETACE, CHLOROTRIANISENETAGAMET, CIMETIDINETAGAMET, CIMETIDINE HYDROCHLORIDETALWIN, PENTAZOCINE HYDROCHLORIDETAUUN, PENTAZOCINE LACTATETALWIN COMPOUND, ASPIRINTANDEARIL, OXYPHENBUTAZONETAO, TROLEANDOMYCINTAPAZOLE, tfETHIMAZOLETARACTAN, CHLORPROTHIXENETATUM-T, COPPERTAVIST, CLEMASTINE FUMARATETAVIST-1, CLEMASTINE FUMARATETC 99M-LUNGAGGREGATE, TECHNETIUM, TC-99M, ALBUMIN AGGREGATEDTECHNECOLL, TECHNETIUM, TC-99M, SULFUR COLLOID KITTECHNESCAN MAA, TECHNETIUM, TC-99M, ALBUMIN AGGREGATED KITTECHNESCAN MDP KIT, TECHNETIUM, TC-99M, MEDRONATE KITTECHNESCAN PYP KIT, TECHNETIUM, TC-99N, PYROPHOSPHATE KITTECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT, TECHNETIUM, TC-99M,ETIDRONATE KITTECHNETIUM TC 99M DTPA (SN) KIT, TECHNETIUM, TC-99N, PENTETATEKITTECHNETIutl.TC 99M GENERATOR, TECHNETIUM, TC-99MGENERATOR/SODIUM PERTECHNETATE, TC-99M.TECHNETIUH TC 99M SULFUR COLLOID, TECHNETIUM, TC-99M, SULFURCOLLOIDTEEBACIN, SODIUM AMINOSALICYLATETEGOPEN, CLOXACILLIN SODIUM MONOHYDRATETEGRETOL, CARBAMAZEPINETELEPAQUE, IOPANOIC ACIDTEMARIL, TRIMEPRAZINE TARTRATETENSILON, EDROPHGtUUM CHLORIDETENUATE, DIETHYLPROPION HYDROCHLORIDETEPANIL, DIETHYLPROPION HYDROCHLORIDETEPANIL TEN-TAB, DIETHYLPROPION HYDROCHLORIDETERFONYL, TRISULFAPYRIHIDINESTERRAMYCIN, LIDOCAINE HYDROCHLORIDETERRAMYCIN, OXYTETRACYCLINETERRAMYCIN, OXYTETRACYCLINE CALCIUMTERRAMYCIN, OXYTETRACYCLINE HYDROCHlORIDETERRAMYCIN W/ POLYMYXIN, OXYTETRACYCLINE HYDROCHLORIDETERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDETERRAMYCIN-POLYMYXIN, OXYTETRACYCLINE HYDROCHLORIDETESLAC, TESTOLACTONETESSALON, BENZONATATETESTOSTERONE, TESTOSTERONETESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATETESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATETESTOSTERONE PROPIONATE, TESTOSTERONE PROPIONATETESTRED, METHYLTESTOSTERONETESULOID, TECHNETIUM, TC-99M, SULFUR COLLOID KITTETRACHEL, TETRACYCLINE HYDROCHLORIDETETRACYCLINE, TETRACYCLINETETRACYCLINE HCL, TETRACYCLINETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETETRACYN, TETRACYCLINETETRACYN, TETRACYCLINE HYDROCHLORIDETETRAMED, TETRACYCLINETETREX, TETRACYCLINE PHOSPHATE COMPLEXTEXACORT, HYDROCORTISONETHALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201THAM, TROMETHAMINETHAM-E, POTASSIUM CHLORIDETHEELIN, ESTRONETHEO-DUR, THEOPHYLLINETHEOLAIR, THEOPHYLLINETHEOLIXIR, THEOPHYLLINETHEOPHYLLINE'-THEOPHYLLINETHIAMI~E HCL, THIAMINE HYDROCHLORIDETHIO-TEPA, THIOTEPATHIOGUANINE, THIOGUANINETHIOMERIN SODIUM, MERCAPTOMERIN SODIUMTHIOSULFIL, SULFAMETHIZOLETHORAZINE, CHLORPROMAZINE HYDROCHLORIDETHYPINONE, PROTIRELINTHYROGLOBULIN, THYROGLOSULINTHYROLAR-O.25, LEVOTHYROXINE SODIUMTHYROLAR-0.5, LEVOTHYROXINE SODIUMTHYROLAR-1, LEVOTHYROXINE ?ODIUMTHYROLAR-2, LEVOTHYROXINE SODIUMTHYROLAR-3, LEVOTHYROXINE SODIUMTHYROLAR-5, LEVOTHYROXINE SODIUMTHYTROPAR, THYROTROPINTICAR, TICARCILLIN DISODIUHTIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
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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 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
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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