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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX10CLAY-PARK LABSHYDROCORTISONE, HYDROCORTISONENITROFURAZONE, NITROFURAZONENYSTATIN, NYSTATINCM BUHD·YBUTABARBITAl, BUTABARBITAl SODIUMDIPHENHYDRAMINE HCl, DIPHENHYDRAMINE HYDROCHLORIDEMEClIZINE HCl, MEClIZINE HYDROCHLORIDEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONERAUWOLFIA SERPENTINA, RAUWOLFIA SERPENTINARESERPINE, RESERPIN~COHSOLZDATED MIOlAHDTEEBACIN, SODIUM AMINOSAlICYLATECOOK-NAITE/STEI?LrHSCARBOCAINE HCl, MEPIVACAINE HYDROCHLORIDECARBOCAINE HCl W/ NEO-COBEFRIN. lEVONORDEFRINRAVOCAINE HCl AND NOVOCAIN W/ LEVOPHED, lEVARTERENOLBITARTRATERAVOCAINE HCl AND NOVOCAIN W/ NEO-COBEFRIN, lEVONORDEFRINLABSACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHENAMINOPHYllINE, AMINOPHYllINEAMITRIPTYLINE HCl, AMITRIPTYLINE HYDROCHLORIDEAQUATAG, BENZTHIAZIDEBROMPHENIRAIUNE MALEATE. BROMPHENIRAMINE MALEATEBUTAl COMPOUND, ASPIRINCAFFEINE AND ERGOTAMINE TARTRATE. CAFFEINECHLORDIAZEPOXIDE HCl, CHLORDIAZEPOXIDE HYDROCHLORIDECHlORFHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATECHLORPROMAZINE HCl, CHLORPROMAZINE HYDROCHLORIDECODAP, ACETAMINOPHENCONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDCORTANE, BROMPHENIRAMINE MALEATEDEXAMETHASONE, DEXAMETHASONEDEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATEDIPHENHYDRAMINE HCl, DIPHENHYDRAMINE HYDROCHLORIDEESTERIFIED ESTROGENS, ESTROGENS. ESTERIFIEDGLUTETHIMIDE, GLUTETHIMIDEHYDRALAZINE HCl, HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEIMIPRAMINE HCl, IMIPRAMINE HYDROCHLORIDElOtl0XATE, ATROPINE SULFATENEPROBAttATE. MEPROBAMATENETHOCARBAMOL, tlETHOCARBAMOlNIACIN, NIACINPAN-TRACE, PREDNISONEPHENDIMETRAZINE TARTRATE. PHENDIMETRAZINE TARTRATEcn~DCORD LABSPHEtHERMINE HCl, PHENTERMINE HYDROCHLORIDEPHENYLBUTAZONE, PHENYLBUTAZONEPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROMETHAZINE HCl, PROMETHAZINE HYDROCHLORIDEPROPANTHElINE BROMIDE, PROPANTHELINE BROMIDEPROPOXYPHENE COMPOUND 65, ASPIRINPROPOXYPHENE HCl, P~OPOXYPHENE HYDROCHLORIDEQUINIDINE SULFATE, QUINIDINE SULFATERAUWOLFIA SERPENTINA, RAUWOLFIA SERPENTINARESERPINE, RESERPINESODIUM BUTABARBITAl, BUTABARBITAl SODIUMSODIUM HEPARIN, HEPARIN SODIUMSONAZINE, CHLORPROMAZINE HYDROCHLORIDESPIRONOLACTONE, SPIRONOLACTONESPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDESULFAMETHOXAZOlE, SUlFAMETHOXAZOlESULFISOXAZOLE. SUlFISOXAZOl.ETOLBUTAMIDE, TOLBUTAMIDETRIAMCINOLONE, TRIAMCINOLONECREIJOLIDOCAINE, lIDOCAINECUTTER LABSALCOHOL 570 IN DEXTROSE 570, ALCOHOLCYTAl, MANNITOLDEXTROSE 570 AND SODIUM CHLORIDE 0.270 IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 570 AND SODIUM CHLORIDE 0.4570 IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 570 IN PLASTIC CONTAINER, DEXTROSEINTRA lIPID lOX. SOYBEAN OILlACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDElIDOCAINE HCl. LIDOCAINE HYDROCHLORIDEMANNITOL lOX, MANNITOLMANNITOL 1570, MANNITOLMAI\'NITOi. 207., MANNI.TOlPOTASSIUM CHLORIDE, POTASSIUM CHLORIDEPROCAINE HCl. PROCAINE HYDROCHLORIDER-GENE 10, ARGININE HYDROCI-!LORIDESODIUM CHLORIDE, SODIUM CHLORIDESODIUM CHlQRIDE IN PLASTIC CONTAINER, SODIUM CHLORIDESTERILE WATER IN PLASTIC CONTAINER. WATER FOR IRRIGATIONVEINAMINE 87., AMINO ACIDS
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX11** D **D-M I'H~,RNACF.UT!CALSCHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECHLORPRmfAZINE HCL, CHLORPROMAZINE HYDROCHLORIDECORTISONE ACETATE, CORTISONE ACETATECYANOC08ALAMHl, CYANOCOBALAMIN 'DE;O(AMETHASONE SODIUtl PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEDItlENHYDRINATE, DIMENHYDRINATEDIPHENHYDRAMINE HCL. DIPHENHYDRAMINE HYDROCHLORIDEDISODIUM EDETATE, EDETATE DISODIUMHYDROCOBALAtlIN. HYDROXOCOBALAMINHYDROCORTISONE ACETATE, HYDROCORTISOI'lE ACETATELIDOCAINE HCL. LIDOCAINE HYDROCHLORIDELIDOCAINE HCL W/ EPINEPHRINE. EPINEPHRINENETHYLPREDISOLONE ACETATE, METHYLPREDNISOLONE ACETATEPREDNISOLONE ACETATE, PREDNISOLONE ACETATEPROCAINE HCL, PROCAINE HYDROCHLORIDEPROMETHAZINE HCL, PRotlETHAZINE HYDROCHLORIDEPYRIDOXINE HCL, PYRIDOXINE HYDROCHLORIDETESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATETESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATETESTOSTERONE PROPIONATE. TESTOSTERONE PROPIONATETHIAMINE HCL, THIAtlINE HYDROCHLORIDETRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATEDAH9!.IRY F'11AP.M!:CALBETHANECHOL CHLORIDE. BETHM~ECHOL CHLORIDEBROf1PHENIRAMINE MALEATE, BROMPHENIRAMINE MALEATECHLOROTHIAZIDE, CHLOROTHIAZIDECHLORPHENIRANINE MALEATE, CHLORPHENIRAMINE MALEATECOL-PROBENECID, COLCHICINEDEXANETHASONE, DEXAMETHASONEDIPHENHYDRAMINE HCL, DIPHENHYDRAtlINE HYDROCHLORIDEERYTHROMYCIN ESTOLATE. ERYTHROMYCIN ESTOLATEFOLIC ACID. FOLIC ACIDGLUTETHIMIDE, GLUTETHINIDEHYDRALAZINE HCL. HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE W/ RESERPINE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE, HYDRALAZINE HCL AND RESERPINE,HYDRALAZINE HYDROCHLORIDEHYDROCORTISONE. HYDROCORTISONEISONIAZID, ISONIAZIDMEPROBAtlATE. MEPR05AtfATEMETHOCARBAMOL. METHOCARBAtfOLMETHYLTESTOSTERONE, METHYLTESTOSTERONENIACIN, NIACINPH ENYTOIN SOD IUM, PH ENYTOIN SOD!UMPREDNISOLONE, FREDNISOLONEPREDNISONE. PREDNISONEPRIMIDONE, PRIMIDONEDMmU~YFHM!r~ACALPROBEf'iECID, PROBENECIDPROCAItlAMIDE HCL, PROCAINAMIDE HYDROCHLORIDEPROMETHAZINE HCL. PROMETHAZINE HYDROCHLORIDEPROPANTHELINE BROMIDE, PROPANTHELINE BROf1IDEPROPOXYPHENE HCL. PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE, QUINIDINE SULFATERAUWOLFIA SERPEtHINA, RAUWOLFIA SERPEtHINARESERPINE, RESERPINETRIAMCINOLOHE, TRIANCINOLONETRICH LORI1ETHIAZIDE, TRICH LORMETHIAZIDETRIHEXYPHENIDYL HCL, TRIHEXYPHENIDYL HYDROCHLORIDETRIPELENNAMINE HCL, TRIPElENNAMINE HYDROCHLORIDETRIPROLIDINE HCL, TRIPROLIDINE HYDROCHLORIDEDAH:!ELS PHARHSQUINIDINE SULFATE, QUINIDINE SULFATEDAns a GECK/1l!1 CYAIfFLAXEDIL, GALLAMINE TRIETHIODIDEPRE-OP, HEXACHLOROPHENEDEL-RAY LABSDEL-VI-A, VITAMIN A PALMITATEDELCO CHEM:!:CALDELCOBESE. AMPHETAMINE ADIPATEDELL LA'?SCYANOCOBALAMIN, CYANOCOBALAMINDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEHEPARIN SODIUM, HEPARIN SODIUMLIDOCAINE HCL. LIDOCAINE HYDROCHLORIDELIDOCAINE HCL WI EPINEPHRINE, EPINEPHRINEPYRIDOXINE HCL, PYRIDOXINE HYDROCHLORIDETHIA~IINE HCL. THIAMINE HYDROCHLORIDEDERHIK lABS/nr~ERHYTONE, HYDROCORTISONEDEY L~·BSISOETHARINE HCL, ISOETHARINE HYDROCHLORIDEDIAGHOSTrC ISOTO;>ESDTPA (SN) KIT (CHELATE), TECHNETIUM, TC-99M, PENTETATE KITGALLIUM CITRATE GA 67. GALLIUM CITRATE, GA-67~1DP KIT, TECHNETIUM, TC-99M, MEDRm~ATE KITSElEHO~fETHIONINE SE 75, SELENmlETHIONINE, SE-75SODIUM POLYPHOSPHATE-TIN KIT, TECHNETIUM, TC-99M,POLYPHOSPHATE KITTECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT, TECHNETIUM, TC-99M,ETIDRONATE KIT
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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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j./APPROVED PRESCRIPTION DRUG PRODU
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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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