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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX20LEUF-RLE LAB!;/AM CYAHDIAtlOX, ACETAZOL#IIDE SODIUMDIHYDROERGOTOXINE METHANESULFONATE, DIHYDROERGOCORNINEMESYLATEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEDIPHENOXYLATE HCL AND ATROPINE SULFATE, ATROPINE SULFATEDOLENE, PROPOXYPHENE HYDROCHLORIDEDOLENE AP-65, ACETAMINOPHENDOLENE COMPOUND-65, ASPIRINERYTHROMYCIN STEARATE, ERYTHROMYCIN STEARATEFOLVITE, FOLATE SODIUMFOLVITE, FOLIC ACIDFOLVRON, FERROUS SULFATEFOLVRON G, ASCORBIC ACIDHEPARIN, HEPARIN SODIUMHEPARIN SODIUtl, HEPARIN SODIUMHETRAZAN, DIETHYLCARBAMAZINE CITRATEHYDRALAZINE HCL, HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROtIOX, QUINETHAZONEHYDROIlOX R, QUINETHAZONEIMIPRAMINE HCL, IMIPRAtlINE HYDROCHLORIDELEDERCILLIN VK, PENICILLIN V POTASSIUMLEUCOVORIN CALCIUM, LEUCOVORIN CALCIUMLEVOFRotIE, METHOTRIMEPRAZINELOXITANE, LOXAPINE HYDROCHLORIDELOXITANE, LOXAPINE SUCCINATEMEPROBAMATE, MEPROBAtlATEMETHOCARBAttOL, METHOCARBAHOLMETHOTREXATE, METHOTREXATEMETHOTREXATE, ttETHOTREXATE SODIUI1MINOCIN, HINOCYCLmE HYDROCHLORIDEMYAMBUTOL, ETHAttBUTOL HYDROCHLORIDEt~EOl1YCIN SULFATE, NEotlYCIN SULFATENEPTAZANE, METHAZOLAMIDENIACIN, NIACINNILSTAT, NYSTATINOXYTETRACYCLINE HCL, OXYTETRACYCLINE HYDROCHLORIDEPATHILON, TRIDIHEXETHYL CHLORIDEPENICILLIN G POTASSIUM, PENICILLIN G POTASSIUMPHENYTOIN SODIUM, PHENYTOIN SODIUMPREDNISONE, PREDNISONEPROBENECID, PROBENECIDPROBENECID 1~1 COLCHICINE, COLCHICINEPROCAINAMIDE HCL, PROCAINAMIDE HYDROCHLORIDEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPROPANTHELINE BROMIDE, PROPAtHHELINE BROMIDEPROPYLTHIOURACIL, PROPYLTHIOURACILPYRAZINAMIDE, PYRAZINAMIDE~UINIDINESULFATE, QUINIDINE SULFATERESERPINE, RESERPINESERVISONE, PREDtHSONELEOEP.L.E LABS/AM CYAtl cSULFADIAZINE, SULFADIAZINESULFADIAZINE SODIUM, SULFADIAZINE SODIUMSULFASALAZINE, SULFASALAZINESULFISOXAZOLE, SULFISOXAZOLETHIO-TEPA, THIOTEPATOLBUTAMIDE, TOLBUTAMIDETRIPLE SULFAS, TRISULFAPYRIMIDINESVITAMIN A, VITAMIN APAREHTERALSAMICAR, AMINOCAPROIC ACIDLEOf.~LELEHMNI !:'HARMACALADIPEX, PHENTERMINE HYDROCHLORIDEADIPEX 8, PHENTERMINE HYDROCHLORIDEADIPEX-P, PHENTERMINE HYDROCHLORIDEANTIPRESS, IMIPRAMINE HYDROCHLORIDEBROMPHEIURAMINE MALEATE, BROMPHENIRAMINE MALEATEBUTABARBITAL SODIUM, BUTABARBITAL SODIUMCHLORPHEIURAMINE MALEATE, CHLORPHENIRAMINE MALEATECOBAVITE, CYANOCOBALAMINDEXAMPEX, DEXTROAMPHETAMINE SULFATEDIETHYLPROPION HCL, DIETHYLPROPION HYDROCHLORIDEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEDRALSERP, HYDRALAZINE HYDROCHLORIDEDRALZINE, HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HCL, HYDRALAZINE HYDROCHLORIDEHYDROCORTISONE, HYDROCORTISONELEMISERP, RESERPINELEMPROtlETH, PR0l1ETHAZINE HYDROCHLORIDEHEPRIAI1, MEPROBAMATEMETHAMPEX, METHAMPHETAMINE HYDROCHLORIDENEOTHYLLINE, DYPHYLLINEPHlTOBARBITAL SODIUtl, PENTOBARBITAL SODIUMPHENDHIETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPREDNISOLONE, PREDHISOLONEPREDNISONE, PREDNISONEQUAALUDE, METHAQUALONESEDS-TENS SE, HOMATROPINE HETHYLBROMIDESTATOBEX, PHENDItfETRAZINE TARTRATESTATOBEX-G, PHENDIMETRAZINE TARTRATETRIPROLIDINE HCL, TRIPROLIDINE HYDROCHLORIDEVITAMIN A SOLUBILIZED, VITAMIN A PALMITATE·LYFHO-Hl:DCHLORPROMAZINE HCL, CHLORPR0l1AZINE HYDROCHLORIDECHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONICCYANOCOBALAMIN, CYANOCOBALAMINDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEHEPARIN SODIUM, HEPARIN SODIUMHYDROXOCOBALAMIN, HYDROXOCOBALAMIN
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX21LyrHO-MEOLIDOCAINE HCL, LIDOCAINE HYDROCHLORIDEtIANNITOL, MANNITOLSODIUM HEPARIN, HEPARIN SODIUM** M **MALLAR!)FENYLHIST, DIPHE~iYDRAMINE HYDROCHLORIDEFENYLHIST-25, DIPHENHYDRANINE HYDROCHLORIDEtIEPROBAtIATE, MEPROBAMATENITROFURAZONE, NITROFURAZONEPHENZIt~E, PHENDItIETRAZINE TARTRATERESERPINE, RESERPINEMALLT.HCKP.OnTANGIO-Cot~RAY, IOTHALAMATE SODIUMCHLORtlERODRIN HG 197, CHLORMERODRIN, HG-197CHOLEBRINE, IOCETAMIC ACIDCONRAY, IOTHALAMATE MEGLU:1INECONRAY-30, IOTHALANATE t!EGLU!1INECOtiRAY-325, IOTHALAMATE SODIUMCONRAY-400, IOTHALAMATE SODIUI1CYANOCOBALAMIN CO 57, CYANOCOBALAMIN, CO-57CYSTO-CONRAY, IOTHALAMATE MEGLUMINECYSTO-CONRAY II, IOTHALMIATE MEGLUMINEDItlERAY, IOCARtlATE MEGLUMINEFERROUS CITRATE FE 59, FERROUS CITRATE, FE-59GALLIlJtl CITRATE GA 67, GALLIUM CITRATE, GA-67HIPPURAN I 131, IODOHIPPURATE SODIUM, 1-131HYZYD, ISONIAZIDMETHADOSE, METHADONE HYDROCHLORIDEPERCHLORACAP, POTASSIUN PERCHLORATEPHOSPHOCOL P 32, CHROMIC PHOSPHATE. P-32RADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 125, ALBUMIN,IODINATED, 1-125, SERUMRADIOIODINATED SER~1 ALBUMIN (HUMAN) IHSA I 131, ALBUMIN,IODINATED, 1-131, SERUMSELENOtIETHIONINE SE 75, SELEN0I1ETHIONINE, SE-75SODIUM CHROMATE CR 51, SODIUM CHROMATE, CR-51SODIUM IODIDE I 125, SODIUM IODIDE, 1-125SODIUM IODIDE I 131, SODIUM IODIDE, 1-131SODIUM PHOSPHATE P 32, SODIUM PHOSPHATE, P-32SODIUM ROSE BENGAL I 131, SODIUM ROSE BENGAL, 1-131TECHNECOLL, TECHNETIUM, TC-99M. SULFUR COLLOID KITTECHNESCAN MAA. TECHNETIUM, TC-99M, ALBUMIN AGGREGATED KITTECHNESCAN PYP KIT, TECHNETIUM. TC-99M, PYROPHOSPHATE KITTHALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE, TL-201TRIOLEIN I 131, TRIOLEIN. 1-131ULTRA-TECHNEKOW FM. TECHNETIUM, TC-99M GENERATOR/SODIUMPERTECHNETATE, TC-99MVASCORAY, IOTHALAMATE MEGLUMINEMALLZtiPKRODTXENEISOL, XENON, XE-133MAIWS'ACTUR'!tiG CHEMPHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEMARrot! LABSDITROPAN, OXYBUTYNIN CHLORIDEFlUONID, FLUOCINOLONE ACETONIDESILVADENE, SILVER SULFADIAZINEVENTAIRE. PROTOKYLOL HYDROCHLORIDEMARSCHALL/MILES LABSPOTASSIUM AMINOSALICYLATE, POTASSIUM AMINOSALICYLATESODIUM AMINOSALICYLATE, SODIUM AMINOSALICYLATES'HARHACALCHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATERESERPINE, RESERPINESODIUM BUTABARBITAL, BUTABARBITAL SODIUMMAR~~ALLMAI/R~YB!OLo~tCALCYCLOPENTOLATE HCL, CYCLOPENTOLATE HYDROCHLORIDED EXAMETHASOtiE SOD!UM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEHYDROCORTISONE ACETATE, HYDROCORTISONE ACETATEHYDROXYPROGESTERCNE CAPROA~E, HYDROXYPROGESTERONE CAPROATELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDENAPHAZOLINE HCL, NAPHAZOLINE HYDROCHLORIDEPREDNISOLONE ACETATE, PREDNISOLONE ACETATEPREDNISOLOtIE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDESODIUM HEPARIN, HEPARIN SODIUMSODIUM SULFACETAMIDE, SULFACETAMIDE SODIUMTRIAMCINOLONE DIACETATE, TRIAMCINOLONE DIACETATEMCNF.l'L LABSBUTICAPS, BUTABARBITAL SODIUMBUTISOL SODIUM, BUTABARBITAL SODIUMCLISTHI. CAR6INOXAMINE MALEATEHALDOL, HALOPERIDOLMOTOFEN, ATROPINE SULFATEMOTOFEN HALF-STRENGTH, ATROPINE SULFATEPARAFLEX, CHLORZOXAZONETOLECTIN, TOLtlETIN SODIUMTOLECTIN DS, TOLMETIN SODIUMTYLENOL W/ CODEINE, ACETAMINOPHENTYLOX, ACETAMINOPHEN
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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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