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

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APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX2AMITID, AMITRIPTYLINE HYDROCHLORIDEAMITRIL, AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HCL, AMITRIPTYLINE HYDROCHLORIDEAf1MONIUM CHLORIDE, ANHONIUM CHLORIDEAf1MONIUM CHLORIDE IN ISOTONIC SODIUM CHLORIDE, AMMONIUM CHLORIDEAMNESTROGEN, ESTROGENS, ESTERIFIEDAMOSENE, MEF'ROBAtIATEAf'lOXICILLIN, AMOXICILLIN TRIHYDRATEAMOXICILLIN TRIHYDRATE, AMOXICILLIN TRIHYDRATEAMOXIL, ANOXICILLIN TRIHYDRATEAMPHICOL, CH LORAtlF'HENICOLAMPICILLIN, AMPICILLIN/AMPICILLIN TRIHYDRATEAMPICILLIN SODIUM, AMPICILLIN SODIUMAMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATEAN-tIDP, TECHNETIUM, TC-99M, MEDRONATE KITANADROL-50, OXYMETHOLONEANAVAR, OXANDROLONEANCEF, CEFAZOLIN SODIUMANC060N, FLUCYTOS!NEANECTINE, SUCCINYLCHOLINE CHLORIOEANESTACON, LIDOCAINE HYDROCHLORIDEANGIO-CONRAY, IOTHALAMATE SOOIUNANHYDRON, CYCLOTHIAZIDEANISOTROPINE METHYLBROMIDE, ANISOTROPINE METHYLBRONIDEANSPOR, CEPHRADINEANTABUSE, DISULFIRAMANTAGONATE, CHLORPHENIRAMINE MALEATEANTE PAR , PIPERAZINE CITRATEANTIMINTH, PYRANTEL PAMOATEANTIPRESS, IMIPRAMINE HYDROCHLORIDEANTIVERT, MECLIZINE HYDROCHLORIDEANTRENYL BROMIDE, OXYPHENONIUM BROMIDEANTUITRIN S, GONADOTROPIN, CHORIONICANTURANE, SULFINPYRAZONEAPAP W/ CODEINE, ACETA~IINOPHENAPAP W/ CODEINE PHOSPHATE, ACETAMINOPHENAPC W/ BUTALBITAL, ASPIRINAPRESAZIDE, HYDRALAZINE HYDROCHLORIDEAPRESOLINE, HYDRALAZINE HYDROCHLORIDEAPRESOLINE-ESIDRIX, HYDRALAZINE HYDROCHLORIDEAQUAf'IEPHYTON, PHYTONADIONEAQUASOL A, VITAMIN AAQUATAG, BENZTHIAZIDEAQUATENSEN, METHYCLOTHIAZIDEAQUEX, TRICHLORMETHIAZIDEARALEN HCL, CHLOROQUINE HYDROCHLORIDEARALEN PHOSPHATE, CHLOROQUINE PHOSPHATEARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE, CHLOROQUINE PHOSPHATEARAMINE, METARAMINOL BITARTRATEARESTOCAINE HCL, MEPIVACAINE HYDROCHLORIDEARESTOCAINE HCL W/ LEVONORDEFRIN, LEVONORDEFRINARFONAD, TRIMETHAPHAN CAMSYLATEARISTOCORT, TRIAMCINOLONEARISTOCORT, TRIAMCINOLONE ACETONIDEARISTOCORT, TRIAMCINOLONE DIACETATEARISTOCORT A, TRIAMCINOLONE ACETONIDEARISTOGEL, TRIAMCINOLONE ACETONIDEARISTOSPAN, TRIAMCINOLONE HEXACETONIDEARTANE, TRIHEXYPHENIDYL HYDROCHLORIDEASBRON, THEOPHYLLINE SODIUM GLYCINATEASELLACRIN, SOMATROPINATARAX, HYDROXYZINE HYDROCHLORIDEATHROMBIN, WARFARIN SODIUMATHRotIBIN-K, WARFARIN POTASSIUMATIVAN, LORAZEPANATROMID-S, CLOFIBRATEATROPEN, ATROPINEAUREOMYCIN, CHLORTETRACYCLINE HYDROCHLORIDEAVENTYL HCL," NORTRIPTYLINE HYDROCHLORIDEAVLOSULFON, DAPSONEAZENE, CLORAZEPATE MONOPOTASSIUMAZOLID, PHENYLBUTAZONEAZULFIDINE. SULFASALAZINE** B **BACI-RX, BACITRACINBACIGUENT, BACITRACINBACITRACIN, BACITRACINBACITRACIN-NEOMYCIN-POLYMYXIN B, BACITRACIN ZINCBACTOCILL, OXACILLIN SODIUM MONOHYDRATEBACTRIM, SULFAMETHOXAZOLEBACTRIM OS, SULFAMETHOXAZOLEBACTRIM PEDIATRIC, SULFAMETHOXAZOLEBAL, DIMERCAPROLBANTHINE, METHANTHELINE BROMIDEBAX, DIPHENHYDRAMINE HYDROCHLORIDEBECLOVENT, BECLOMETHASONE DIPROPIONATEBENADRYL, DIPHENHYDRAMINE HYDROCHLORIDEBEND ECTIN, DOXYLAMINE SUCCINATEBENDOPA, LEVODOPABENEMID, PROBENECIDBENIsmlE, BETAMETHASONE BENZOATEBEr-.:OQUIN, MONOBEt/ZONEBENOXINATE HCL, BENOXINATE HYDROCHLORIDEBENSULFOID, BENTONITEBENZEDRINE, AMPHETAMINE SULFATEBENZTHIAZIDE, BENZTHIAZIDEBENZYL BENZOATE, BENZYL BENZOATEBERUBIGEN, CYANOCOBALAMINBETA LIN S, THIAMINE HYDROCHLORIDEBETA LIN 12, CYANOCOBALAMIN
APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX3BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE SODIUM PHOSPHATEBETAPAR, MEPREDNISONEBETAPEN-VK, PENICILLIN V POTASSIUMBETAPRONE, PROPIOLACTONEBETHANECHOL CHLORIDE, BETHANECHOL CHLORIDEBICILLIN, PENICILLIN G BENZATHINEBICILLIN C-R, PENICILLIN G BENZATHINEBICILLIN L-A, PENICILLIN G BENZATHINEBICNU, CARtlUSTINEBILOPAQUE SODIUM, TYROPANOATE SODIUMBIOCYCLHIE, TETRACYCLINEBIPHETAMINc 12.5, AMPHETAMINE RESIN COMPLEXBIPHETAMINE 20, AMPHETAMINE RESIN COtlPLEXBIPHETAMINE 7.5, AtlPHETAMINE RESIN COMPLEXBLENOXANE, BLEOMYCIN SULFATEBLEPH-10, SULFACETAMIDE SODIUMBLEPH-30, SULFACETAMIDE SODIUMBONE SCANNING KIT, TECHNETIUtl, TC-99M, PYROPHOSPHATE KITBRETHINE, TERBUTALINE SULFATEBRETYLOL, BRETYLIUM TOSYLATEBREVICON 21, ETHINYL ESTRADIOLBREVICON 28, ETHINYL ESTRADIOLBREVITAL SODIUtl, METHOHEXITAL SODIUMBRICANYL, TERBUTALINE SULFATEBRISTACYCLINE, TETRACYCLINE HYDROCHLORIDEBRISTAMYCIN, ERYTHROMYCIN STEARATEBRotlPHENIRAMINE MALEATE, BROtlPHENIRAMINE MALEATEBRONKODYL, THEOPHYLLINEBRONKOMETER, ISOETHARINE MESYLATEBRONKOSOL, ISOETHARINE HYDROCHLORIDEBRYREL, PIPERAZINE CITRATEBUCLADIN-S, BUCLIZINE HYDROCHLORIDEBUFFERED PARASAL-INH 20, AMINOSALICYLIC ACIDBUPIVACAINE HCL, BUPIVACAINE HYDROCHLORIDEBUTABARB, BUTABARBITAL SODIUMBUTABARBITAL, BUTABARBITAL SODIUMBUTABARBITAL SODIutl, BUTABARBITAL SODIUMBUTAL COMPOUND, ASPIRINBUTALAN, BUTABARBITAL SODIUMBUTALBITAL W/ APC, ASPIRINBUTAZOLIDIN. PHENYLBUTAZONEBUTICAPS, BUTABARBITAL SODIUMBUTISOL SODIUM, BUTABARBITAL SODIUM** C **CAFERGOT, CAFFEINECAFFEINE AND ERGOTAMINE TARTRATE, CAFFEINECALCIMAR, CALCITONIN, SALMONCALCIUM GLUCEPTATE, CALCIUM GLUCEPTATECALMURID HC, HYDROCORTISONECAM-AP-ES, HYDRALAZINE HYDROCHLORIDECAM-METRAZ!NE, PHENDIMETRAZINE TARTRATECAnOQUIN HCL, AMODIAQUINE HYDROCHLORIDECANDEPTIN, CANDICIDINCAND EX , NYSTATINCANTIL, MEPENZOLATE BROMIDECAPASTAT SULFATE, CAPREOMYCIN SULFATECAPITAL W/ CODEINE, ACETAMINOPHENCAPITROL, CHLOROXINECARBOCAINE HCL, MEPIVACAINE HYDROCHLORIDECARBOCAINE HCL W/ NEO-COBEFRIN, LEVONORDEFRINCARDIO-GREEN, INDOCYANINE GREENCARDIOGRAFIN, DIATRIZOATE MEGLUMINECARDIOQUIN, QUINIDINE POLYGALACTURONATECARDRASE, ETHOXZOlAllIDECARISOPRODOL, CARISOPRODOLCARISOPRODOL COMPOUND, CAFFEINECARMOl HC, HYDROCORTISONE ACETATECATAPRES, ClONIDINE HYDROCHLORIDECATARASE, CHYMOTRYPSINCECLOR, CEFACLOR MONOHYDRATECEDIlANID-D, DESLANOSIDECEENU, LotlUSTINECEFADYl, CEPHAPIRIN SODIUMCELBENIN, METHICILLIN SODIUM MONOHYDRATECELESTONE, BETANETHASONECELESTONE, BETAMETHASONE SODIUM PHOSPHATECELESTONE SOLUSPAN, BETAMETHASONE ACETATECELONTIN, METHSUXIMIDECENTRAX, PRAZEPAMCEPHALEXIN MONOHYDRATE, CEPHALEXIN MONOHYDRATECEPHULAC, LACTULOSECERUBIDINE, DAUNORUBICIN HYDROCHLORIDECERUMENEX, TRIETHANOLAMINE POLYPEPTIDE OLEATE CONDENSATECETACORT, HYDROCORTISONECETAMIDE, SULFACETAtlIDE SODIUMCHLOR-TRIMETON, CHLORPHENIRAM!NE MALEATECHLORAMPHENICOL, CHLORAMPHENICOLCHLORDIAZACHEL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLORIDAMINE, CHLORPHENIRAMINE MALEATECHLORMERODRIN HG 197, CHLORMERODRIN, HG-197CH LORtlEZANCNE, CH LORMEZANONECHLOROMYCETIN, CHLORAMPHENICOLCHLOROMYCETIN, CHLORAMPHENICOL SODIUM SUCCINATECHLOROMYCETIN PALMITATE, CHLORAMPHENICOL PALMITATECHLORONYXIN, CHLORAMPHENICOLCHLOROPTIC, CHLORAMPHENICOLCHLOROPTIC S.O.P., CHLORAMPHENICOLCHLOROPTIC-P S.O.P., CHLORAMPHENICOLCHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
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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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APPROVED ¥RESCRIPTION DRUG PRODUCT
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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