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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX24** H **HATCOH CHEm:CALCHlORPHENIRA!1INE MALEATE, CHlORPHENIRAMINE MALEATECYANOCOBALAMIN, CYANOCOBALAMINlIDOCAINE HCl, LIDOCAINE HYDROCHLORIDEPIPERAZINE CITRATE, PIPERAZINE CITRATEPOTASSIUM CHLORIDE, POTASSI~1 CHLORIDEPROPOXYPHENE HCl, PROPOXYPHENE HYDROCHLORIDEPYRIDOXINE HCl, PYRIDOXINE HYDROCHLORIDETHIAmNE HCl, THIAH.INE HYDROCHLORIDEHATl PHAr.M MrG/BAr.~EACETAMINOPHEN WI CODEINE PHQ'SPHATE, ACETAMINOPHENAPAP WI CODEINE, ACETAMINOPJIENBIOCYClINE, TETRACYCLINEBUTABARB, BUTABARBITAl SOD.IUMCHlORIDAMINE, CHlORPHENIRAMINE MALEATECYPROHEPTADINE HCl, CYPROHEPTADINE HYDROCHLORIDEDEXA~IETHASONE, DEXAMETHASONEHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDEHYDROXYZINE HCl, HYDROXYZINE HYDROCHLORIDEISOPROTERENOL HCl, ISOPROTERENOL HYDROCHLORIDElIDOCAINE HCl VISCOUS, lIDOCAINE HYDROCHLORIDElmiANATE, ATROPINE SULFATEPIPERAZINE CITRATE, PIPERAZINE CITRATEPROf'IETH, PROMETHAZINE HYDROCHLORIDESELENIUM SULFIDE, SELENIUM SULFIDETHEOPHYLLINE, THEOPHYLLINETRIPLE SULFA, TRISULFAPYRIMIDINESTRIPROlIDINE HCl,,,TRIPROLIDINE HYDROCHLORIDEHF-N EPGf_A!~1)NUCLEARGALLIUtl CITRATE GA 67, GALLIUM CITRATE, GA-67GLUCOSCAI~, TECHNETIUM, TC-99M, GLUCEPTATE KITOSTEOlITE, TECHNETIUM, TC-99M, MEDRONATE KITPUU10lITE, TECHNETIUM, TC-99M, ALBUMIN AGGREGATED KITPYROLITE, TECtlNETIUM, TC-99M, PYRO/TRItIETA PIiOSPHATES KITTECHNETIUM TC 99~1 GENERATOR, TECHNETIUM, TC-99MGENERATORISODIUtl PERTECHHETATE, TC-99MTHALlOUS CHLORIDE Tl 201, THAlLOUS CHLORIDE, TL-201XENON XE 133, XENON, XE-133HEwnam PHARMSBROMFHENIRAMINE MALEATE, BROMPHENIRAMINE MALEATECHLORPHENIRA~IINE MALEATE, CHLORPHENIRAMINE MALEATEDIPHENHYDRA~IINE HCl, DIPHENHYDRAMINE HYDROCHLORIDEHIr.'Flltl KAYAKU ~oBlENOXANE, BLEOMYCIN SULFATEHCr-:H!CH-F.AT1:!H FHARMALPHADERM, HYDROCORTISONEDANTRIUM, DANTROLENE SODIUMDOPAR,LEVODOPADUVOID, BETHANECHOl CHLORIDEFURACIN, NITROFURAZONEFURADANTIN, NITROFURANTOINFUROXONE, FURAZOLIDONEIvt.DANTIN, NITROFURANTOIN SODIUMMACRODANTIN, NITROFURANTOIN, MACROCRYSTALlINENYSERT, NYSTATINHoVnCQL CtiEH MFGISOCAINE HCl, MEPIVACAINE HYDROCHLORIDEISOCAINE HCl WI lEVONORDEFRIN, lEVONORDEFRIN** 0 **OHIO mm F:l"DS/t;:mcoEnIRAt~E, ENF lURANEFORANE, ISOFLURANEOJF ItUmmOl"ALlOYMETRA, PHEtmulETRAZINE TARTRATEMICROSUl, SUlFAMETHIZOlEPRCKlAR, SUlFAHETHIZOLESUlFAlOID, TRISULFAPYRIMIOINESOJF/ctmCnlALlOYBETAPRONE, FROPIOLACTONERAlJRINE, RESERPINEWOlFINA, RAUWOLFIA SERPENTINAORGAH!C5CORTICOTROPIN, CORTICOTROPINOl
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX25O~GANOM/AKZDHAORGATRAX, HYDROXYZINE HYDROCHLORIDEPAVULON, PANCURONIUM BROMIDEPREGNYL, GONADOTROPIN, CHORIONICPURIFIED CORTROPHIN GEL, CORTICOTROPINREGONOL, PYRIDOSTIGMINE BROMIDESUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDEORTHO PHARMCLODERM, CLOCORTOLONE PIVALATEDIENESTROL, DIENESTROLGRIFULVIN V, GRISEOFULVIN, MICROCRYSTALLINEIMODIUM, LOPERAMIDE HYDROCHLORIDEMICATIN, MICONAZOLE NITRATEMICRONOR, NORETHINDRONEMODICON, ETHINYL ESTRADIOLMODICON 28, ETHINYL ESTRADIOLMONISTAT-7, MICONAZOLE NITRATEORTHO-NOVUM 1/35-21, ETHINYL'ESTRADIOLORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOLORTHO-NOVUM 1/50 21, MESTRANOLORTHO-NOVUM 1/50 28, MESTRANOLORTHO-NOVUM 1/80 21, MESTRANOLORTHO-NOVU~I 10-21, MESTRANOLORTHO-NOVUI1 2-21, MESTRANOLORTHO-NOVUM 1/80 28, MESTRANOLRETIN-A, TRETINOINSALPIX, ACETRIZOATE SODIUMSULTRIN, SULFABENZAMIDEONE" LAB!VALC!lN LABSCETACORT, HYDROCORTISONEGRISO~EN, GRISEOFULVIN, MICROCRYSTALLINEIOSEL 250, SELENIUM SULFIDENUTRACORT, HYDROCORTISONEPAI'!'!AY/O~MOHT** P **D~UGAMINOPHYLLINE, AMINOPHYLLINEBUFFERED PARASAL-INH 20, AMINOSALICYLIC ACIDCHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECINNASI L, RESCINNAtlINECORTISONE ACETATE, CORTISONE ACETATEHYDROCORTISONE, HYDROCORTISONEISONIAZID, ISONIAZIDKOGLUCOID, RAUWOLFIA SERPENTINAPARASAL, AtlINOSALICYLIC ACIDPARASAL SODIUM, SODIUM AtlINOSALICYLATEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREONISm~EPROCAPAN, PROCAINAMIDE HYDROCHLORIDE** P **PANRAY/ORMOHT DRUGSERPANRAY, RESERPINETHEOLIXIR, THEOPHYLLINEPAR PHARMHYDRALAZINE HCL, HYDRALAZINE HYDROCHLORIDEMETHOCARBAMOL, METHOCARBAMOLPAPKE-DAVIS LABS/w-LLOESTRIN FE 1.5/30, ETHINYL ESTRADIOLLOESTRIN FE 1/20, ETHINYL ESTRADIOLLOESTRIN 1.5/30, ETHINYL E,STRADIOLLOESTRIN 21 1120, ETHItIYL ESTRADIOLNORLESTRIN FE 1/50, ETHINYL ESTRADIOLNORLESTRIN FE 2.5/50, ETHINYL ESTRADIOLNORLESTRIN 21 1/50, ETHINYL ESTRADIOLNORLESTRIN 21 2.5/50, ETHINYL ESTRADIOLNORLESTRIN 28 1/50, ETHINYL ESTRADIOLPARKE-DAV!S/N-LACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHENACTH, CORTICOTROPINAMEODRYL HCL, BROMODIPHENHYDRAMINE HYDROCHLORIDEAMCILL, AMPICILLIN/AMPICILLIN TRIHYDRATEAMCILL-S, AI1PICILLIN SODIUMAMITRIL, AMITRIPTYLINE HYDROCHLORIDEANTUITRIN S,GONADOTROPIN, CHORIONICBENADRYL, DIPHENHYDRAMINE HYDROCHLORIDEBENISONE, BETAtlETHASONE BENZOATECAr.OQUIN HCL, Ar-!ODIAQUINE HYDROCHLORIDECELONTIN, METHSUXIMIDECENTRAX, PRAZEPAMCHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLOROMYCETIN, CHLORAMPHENICOLCHLOROMYCETIN, CHLORAMPHENICOL SODIUM SUCCINATECHLOROMYCETIN PALMITATE, CHLORAMPHENICOL PALMITATECHLOROMYXIN, CHLORAMPHENICOLCHOLEDYL, OXTRIPHYLLINECOLY-MYCIN M, COLISTIMETHATE SODIUMCOLY-MYCIN S, COLISTIN SULFATECYCLOPAR, TETRACYCLINE HYDROCHLORIDEDILANTIN, PHENYTOINDIlANTIN, PHENYTOIN SODIUMDILANTIN-125, PHENYTOINDILANTIN-30, PHENYTOINDURAQUIN, QUINIDINE GLUCONATEE-Z SCRUB SURGICAL, ALKYL AMMoNIUM SULFONIC ACID BETAINE(SULFOBETAINE DEH)ELASE W/ CHLOROMYCETIN, CHLORAMPHENICOLERYPAR, ERYTHROMYCIN STEARATE
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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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