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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX16GENERIC PHARM/rVyDIPHENOXYLATE W/ ATROPINE SULFATE, ATRCPINE SULFATEFOLIC ACID, FCLIC ACIDHYDROCHLCRCTHIAZIDE, HYDROCHLORCTHIAZIDEHYDROCHLOROTHIAZIDE W/ RESERPINE, HYDRCCHLORCTHIAZIDEMEPROBAMATE, MEPROBAMATEMETHOCARBAMOL, METHCCARBAMCLNIACIN, NIACINPHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPHENYTCIN SODIUM, PHENYTCIN SCDIUMPREDNISCLONE, PREDNISCLCNEPREDNISONE, PREDNISONEPROMETHAZINE HCL, PROMETHAZINE HYDRCCHLORIDEPROPOXYPHENE HCL, PRCPCXYPHENE HYDROCHLCRIDEPROPYLTHIOURACIL. PROPYLTHICURACILRESERPINE, RESERPINETETRACYCLINE HCL. TETRACYCLINE HYDROCHLCRIDETRIPELENNAMINE HCL. TRIPELENNAMINE HYDROCHLORIDEGLA}{O rm:BECLOVENT. BECLOMETHASONE DIPROPIONATEGLENNOOD LABSMYOTONACHOL, BETHANECHCL CHLORIDEPASKALIUM, POTASSIUM AMINCSALICYLATECHEMICALLIDOCAINE. LIDOCAINELIDOCAINE HCL. LIDOCAINE HYDRCCHLORIDELIDOCAINE HCL 14/ EPINEPHRINE. EPINEPHRINEMEPIVACAINE HCL, MEPIVACAINE HYDROCHLCRIDEMEPIVACAINE HCL W/ LEVONORDEFRIN, LEVCNCRDEFRINGR~HAM** H **HALOCARBon LABSHALOTHANE, HALCTHANEHALSI!::Y (mUGACETAMINOPHEN W/ CODEINE PHCSPHATE, ACETAMINCPHENAMINOPHYLLINE, AMINOPHYLLINEAl1ITRIPTYLINE HCL, AMITRIPTYLINE HYDROCHLORIDECHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE HYDROCHLORIDECHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATECORTALONE, PREDNISOLONEDEXTROAMPHETAMINE SULFATE. DEXTROAMPHETAMINE SULFATEDIPHENOXYLATE HCL AN!) ATRCPINE SULFATE, ATROPINE SULFATEFOLIC ACID, FOLIC ACIDHYDRO-D, HYDROCHLOROTHIAZIDEISONIAZID, ISONIAZIDMEPERIDINE HCL, MEPERIDINE HYDROCHLORIDENEURAMATE, MEPROBAMATEHALSEY DRUGNIACIN. NIACINPREDNISCNE.PREDNISCNEPRCPYLTHIOURACIL, PROPYLTHIOURACILQUINIDINE SULFATE. QUINIDINE SULFATERAUWOLFIA SERPENTINA, RAUWCLFIA SERPENTINARESERPINE. RESERPINESARISCL NO.. 1. BUTABARBITAL SODIUMSARISCL NO.. 2. BUTABARBITAL SOOIUMSODIUM PENTCBARBITAL. PENTOBARBITAL SODIUMSODIUM SECOBARBITAL, SECOBARBITAL SCDIUMTETRACYCLINE HCL. TETRACYCLINE HYDROCHLCRIDETHECPHYLLINE. THECPHYLLINEHEATHF.R DRUGCCNJUGATED ESTROGENS, ESTRCGENS, CONJUGATEDCORTISCNE ACETATE, CORTISCNE ACETATEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEDIPHENOXYLATE HCL AHD ATROPINE SULFATE. ATROPINE SULFATEHYDROCHLORCTHIAZIDE, HYDROCHLORCTHIAZIDEMEPROBAMATE, MEPRCBAMATEMETHOCARBAMOL, METHOCARBAMCLMETHYLPREDNISOLCNE, METHYLPREDNISCLONEPREDNISCLCNE, PREDNISCLONEPREDNISONE, PREDNISCNEPROPANTHELINE BROMIDE, PRCPANTHELINE BROMIDE·SULFISOXAZOLE, SULFISCXAZCLETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDETRIPELENNAMINE HCL, TRIPELENNAMINE HYDRCCHLORIDEVIRILON, METHYLTESTCSTERONEHERBERT LAe/ALLER~AHAERCSEB-DEX, DEXAMETHASONEAEROSEB-HC. HYDROCORTISONEEXSEL, SELENIUM SULFIDEFLUOROPLEX, FLUOROURACILHEtlfi-W:lRNOOD LABSACETAMINOPHEN 14/ CODEINE PHOSPHATE, ACETAMINOPHENACETIC ACID 14/ HYDROCORTISONE. ACETIC ACID, GLACIALAMINOPHYLLINE, AMINOPHYLLINEBROHPHENIRAMINE MALEATE, BROMPHENIRAMINE MALEATEDIHYDROERGOTCXINE METHANESULFONATE, DIHYDROERGOCORNINEtlESYLATEDIPHE~~YDRAMINEHCL, DIPHENHYDRAMINE HYDROCHLORIDEERYTHROMYCIN ETHYLSUCCINATE. ERYTHROMYCIN ETHYLSUCCINATEMETHYLTESTOSTERONE. tlETHYL TESTOSTERONEORLEX, ACETIC ACID, GLACIALPHENDIMETRAZINE TARTRATE. PHE~~IMETRAZINEPREDNISONE, PREDNISONEPROMETHAZINE HCL. PROMETHAZINE HYDROCHLORIDEQUINIDINE SULFATE, QUINIDINE SULFATETARTRATE.. ----'
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX17LABSSODIUM SECOBARBITAL. SECOBARBITAL SODIUMHEU"-HORW~onHOF.OHST-ROUSSF.LLASIX. FUROSEMIDERElEFACT TRH. PROTIRElINTOPICORT. DESOXINETASONETOPICORT lP. DESOXItlET ASONEROCHEANCOBON. FlUCYTOSINEARFONAD. TRIHETHAFHAN CAHSYLATEBACTRIH. SUlFANETHOXAZOLEBACTRIM DS. SULFAHETHOXAZOlEBACTRIM PEDIATRIC. SUlFAMETHOXAZOLECLONOPIN. ClONAZEPAMEFUDEX. FLUOROURACILENDEP. AMITRIPTYLINE HYDROCHLORIDEFLUOROURACIL. FLUOROURACILFUDR. FLOXURIDINEGANTANOL. SULFANETHOXAZOLEGANTANOl-DS. SUlFAHETHOXAZOlEGANTRISIN. SULFISOXAZOLEGANTRISIN. SULFISOXAZOLE ACETYLGANTRISIN. SULFISOXAZOLE DIOLAMINEGANTRISIN PEDIATRIC. SULFISOXAZOLE ACETYLKONAKION. PHYTONADIONELARODOPA. lEVODOPALAROTID, AMOXICILlIN TRIHYDRATELIBRIUtl, CHLORDIAZEPOXIDE HYDROCHLORIDELItlBITROL, AMITRIPTYLINE HYDROCHLORIDELIPO GANTRISIN, SULFISOXAZOLE ACETYLLORFAN, LEVALLORPHAN TARTRATEMATULANE, PROCARBAZINE HYDROCHLORIDEMENRIUM 10-4, CHLORDIAZEPOXIDEMENRIUM 5-2. CHLORDIAZEPOXIDEMENRIUM 5-4, CHLORDIAZEPOXIDEHESTINON, PYRIDOSTIGt1INE BROMIDENIPRIDE, SODIUM NITROPRUSSIDENOLUDAR, METHYPRYlONPROSTIGMIt~ BRotUDE, NEOSTIGMINE BROMIDEQUARZAN. CLIDINIUM BROMIDERINIFON, ISONIAZIDROCALTROL. CAlCITRIOlSOLATENE, CAROTENE, BETASYNKAYVITE, HENADIOl SODIUM DIPHOSPHATETARACTAN, CHLORPROTHIXENETENSIlON, EDROPHONIUM CHLORIDETRINPEX. TRIMETHOPRIMVALIUM. DIAZEPAMHO~~MANH-LAHOllAH!)-IMNTDSKORO-SULF, SULFISOXAZOLEKOROSTATIN, NYSTATINHOYT LABS/C-PORABASE HCA. HYDROCORTISONE ACETATEHt1HTINGTOIf LABSGERMA-MEDICA, HEXACHLOROPHENEGERMA-tlEDICA MG. HEXACHLOROPHENEHEXA-GERM, HEXACHLOROPHENE"YHSH ~ISTCTT DUHNINGBAl, DHlERCAPROlCARDIO-GREEN. INDOCYANINE GREEN** I **IOI AME'R:tCASNOlVADEX. TAMOXIFEN CITRATEICti F'HA~NSAMINOPHYLLINE. AMINOPHYLLINEBENDOPA, LEVODOPACHlORPHENIRAMINE MALEATE. CHlORPHENIRAMINE MALEATECODEINE PHOSPHATE AND ACETAtlINOPHEN, ACETAMINOPHENCONJUGATED ESTROGENS, ESTROGENS. CONJUGATEDDIETHYLSTILBESTROL. DIETHYLSTILBESTROLDIPHENHYDRAI1WE HCl, DIPHENHYDRAMINE HYDROCHLORIDEFOLIC ACID. FOLIC ACIDMEFROBAMATE, MEPROBAMATEPREDNISOLONE, PREDNISOLONEPREDNISmIE. PREDNISONEPROPOXYPHENE HCl. PROPOXYPHENE HYDROCHLORIDEPROPOXYPHENE HCl W/ A.P.C., ASPIRINQUINIDINE SULFATE, QUINIDINE SULFATERAU\·mLFIA SERPENTINA, RAUWOLFIA SERPENTINARESERPINE. RESERPINESODIUM PENTOBARBITAL. PENTOBARBITAL SODIUMSULFISOXAZOLE, SULFISOXAZOLETESTRED, METHYLTESTOSTERONETETRACYCLINE HCL, TETRACYCLINE HYDROCHLORIDEIKAF'HARM LTDAMITRIPTYLINE HCl, AMITRIPTYLINE 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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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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