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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX8** C **CAm) M PHA~HACALHC (HYDROCORTISONE), HYDROCORTISONEHI-COR, HYDROCORTISONECtI~'ALLCMI-AP-ES, HYDRALAZINE HYDROCHLORIDECAM-tlETRAZINE, PHENDIMETRAZINE TARTRATECHLOROTHIAZIDE, CHLOROTHIAZIDEHYDRO-RESERP, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEMECLlzmE HCL, f1ECLIZINE HYDROCHLORIDEPHENAZINE~35, PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPHENTERMINE HCL, PHEIHERMINE HYDROCHLORIDETRICH LORtlETHIAZIDE, TRICHLORMETHIAZIDECARLISLE LABSALPHACAINE, LIDOCAINEALPHACAINE HCL, LIDOCAINE HYDROCHLORIDEALPHACAINE HCL 14/ EPINEPHRINE, EPINEPHRINEARESTOCAINE HCL, MEPIVACAINE HYDROCHLORIDEARESTOCAINE HCL 14/ LEVOJ{ORDEFRIN, LEVONORDEFRINLtl9S/REXALLQUINIDINE SULFATE, QUINIDINE SULFATECtl~m::G!ELABSACETAMINOPHEN 14/ CODEINE PHOSPHATE, ACETAMINOPHENAtlEN, MEDROXYPROGESTERONE ACETATECAPITAL 14/ CODEINE, ACETAMINOPHENCARN~!CKCARTF.R-GLn~AUDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEMETHOCARBAMOL, METHOCARBAMOLMETHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATEPROCAINE HCL, PROCAINE HYDROCHLORIDESOLU-PRED, PREDNISOLONE SODIUM PHOSPHATECtlRTER-GLOGAU LABSAtlITRIPTYlINE HCL, AMITRIPTYlINE HYDROCHLORIDEBETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE SODIUM PHOSPHATEBRotlPHENIRAMINE MALEATE, BRotlPHENIRAMINE MALEATECHLORPHENIRAHINE MALEATE, CHLORPHENIRAMINE MALEATECHORIONIC GON;\DOTROPIN, GONADOTROPIN, CHORIONICCORTISONE ACETATE, CORTISONE ACETATECYANOCOBALAMIN, CYANOCOBALAMINDEXM1ETHASONE ACETATE, DEXAMETHASONE ACETATEDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEDH1ENHYDRINATE, DIMENHYDRINATEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDECARTE~-GlOGAU LABSDURA-LUTIN, HYDROXYPROGESTERONE CAPROATEEDETATE DISODIUM, EDETATE DrSODIUMESTRADIOL VALERATE, ESTRADIOL VALERATEESTRONE, ESTRONEHEPARIN SODIUM, HEPARIN SODIL~HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATEHYDROXOCOBALAMIN, HYDROXOCOBALAMINHYDROXYZINE HCL, HYDROXYZINE HYDROCHLORIDEIRON DEXTRAN, IRON DEXTRAN COMPLEXKLORAZINE, CHLORPROMAZINE HYDROCHLORIDELIDOCAINE HCL, LIDOCAINE HYDROCHLORIDELIDOCAINE HCL 14/ EPINEPHRINE, EPINEPHRINEMERSALYL-THEOPHYLLINE, MERSALYL SODIUMMETHYlPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATEPHENYTOIN SODIUM, PHENYTOIN SODIUMPREDNISOLONE ACETATE, PREDNISOLONE ACETATEPREDNISOLONE TERTIARY BUTYl ACETATE, PREDNISOLONE TEBUTATEPROGESTEROI~E, PROGESTERONEPROMAZINE HCL, PROMAZINE HYDROCHLORIDEPROMETHAZINE HCL, PROMETHAZINE HYDROCHLORIDEPYRIDOXINE HCL, PYRIDOXINE HYDROCHLORIDESOOIUM HEPARIN, HEPARIN SODIUMTESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATETESTOSTERONE PROPIONATE, TESTOSTERONE PROPIONATETHIAMINE HCL, THIAMINE HYDROCHLORIDETRIAMCINOLONE DIACETATE, TRIAMCINOLONE· DIACETATECENTRAL PHARt!ACALDEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATEDIMENHYDRINATE, DIMENHYDRINATEPHENCEN-50, PROMETHAZINE HYDROCHLORIDEPREDNICEN-M, PREDNISONEPREDNISOLONE ACETATE. PREDNISOLONE ACETATESYNOPHYLATE, THEOPHYLLINE SODIUM GLYCINATECEffTL'RY PHARMSP.A.S. SODIUM, SODIUM AMINOSALICYLATECHASE CtfEMJ:CALVITAMIN A, VITAMIN AVITAMIN A, VITAMIN A PALMITATEVITAMIN 0, ERGOCALCIFEROLCHELSEA LABSA.P.C. W/ BUTALBITAL, ASPIRINAMINOPHYlLINE. AMINOPHYLLINEAMITRIPTYlINE HCL, AMITRIPTYlINE HYDROCHLORIDEBETHANECHOL CHLORIDE, BETHANECHOL CHLORIDEBROMPHENIRAMINE MALEATE, BRm1PHENIRAMII~E MALEATEBUTABARBITAL SODIUM, BUTABARBITAL SODIUMCARISOPRODOL, CARISOPRODOL
APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX9CHELSEA LABSCHLORDIAZEPOXIDE HCl, CHLORDIAZEPOXIDE HYDROCHLORIDECHlORPHENIRAMINE MALEATE, CHlORPHENIRAMINE MALEATECHlORPRotlAZINE HCl, CHlORPRONAZINE HYOROCHlORIDECONJUGATED ESTROGENS, ESTROGENS, CONJUGATEDCORTISONE ACETATE, CORTISONE ACETATECYPROHEPTADINE HCl, CYPROHEPTADINE HYDROCHLORIDEDEXAMETHASONE, DEXAMETHASONEDIETHYlPROPION HCl, DIETHYlPROPION HYDROCHLORIDEDINENHYDRINATE, DIME~~YDRINATEDIPHENHYDRAMINE HCl, DIPHENHYDRANINE HYDROCHLORIDEDIPHENOXYlATE HCl W/ ATROPINE SULFATE, ATROPINE SULFATEERYTHROMYCIN STEARATE, ERYTHROMYCIN STEARATEFOLIC ACID, FOLIC ACIDGLUTETHIMIDE, GLUTETHIMIDEGlYCOPYRROlATE, GlYCOPYRROlATEHYDRALAZINE AND HYDROCHlORTHIAZIDE, HYDRALAZINE HYDROCHLORIDEHYDRALAZINE HCl, HYDRALAZINE HYDROCHLORIDEHYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE, HYDRALAZINEHYDROCHLORIDEHYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE W/ RESERPINE, HYDROCHLOROTHIAZIDEHYDROGENATED ERGOT ALKALOIDS, DIHYDROERGOCORNINE MESYlATEIMIPRAMINE HCl, IMIPRAMINE HYDROCHLORIDEISONIAZID, ISONIAZIDMEPROBANATE, MEPROBANATEMETHOCARBA~lOl, METHOCARBAMOlNIACIN, NIACINNITROFURANTOIN, NITROFURANTOINNYSTATIN, NYSTATINPHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATEPHENTERtlINE HCl, PHENTERMINE HYDROCHLORIDEPHENYLBUTAZONE, PHENYLBUTAZONEPHENYTOIN SODIUM, PHENYTOIN SODIUMPREDNISOLONE, PREDNISOLONEPREDNISONE, PREDNISONEPROBEN-C, COLCHICINEPROBENECID, PROBENECIDPROCAINANIDE HCl, PROCAINAMIDE HYDROCHLORIDEPROMETHAZINE HCl, PROMETHAZINE HYDROCHLORIDEPROPOXYPHENE CONPOUND 65, ASPIRINPROPOXYPHENE HCl, PROPOXYPHENE HYDROCHLORIDEPROPYLTHIOURACIL, PROPYLTHIOURACILPYRILAMINE NAlEATE, PYRILAMINE MALEATEQUINIDINE SULFATE, QUINIDINE SULFATERESERPINE. RESERPINESODIUM PENTOBARBITAL. PENTOBARBITAL SODIUMSODIUM SECOBARBITAL, SECOBARBITAL SODIUMSUlFASAlAZINE. SUlFASAlAZINESULFISOXAZOLE. SULFISOXAZOLETETRACYCLINE HCl. TETRACYCLINE HYDROCHLORIDETOLBUTAMIDE, TOLBUTAMIDECHELSEA LABSTRIAMCINOLONE, TRIAMCINOLONETRICHlORMETHIAZIDE, TRICHlORMETHIAZIDETRIPELENNAMINE HCl, TRIPELENNAMINE HYDROCHLORIDECHESEBR~U!3H-l'mrosACTIN-N, NITROFURAZONEVIRAC REX, UNDECOYlIUM CHLORIDEcrSA PHAJ:1HANTRENYl BROMIDE. OXYPHENONIUM BROMIDEANTURANE, SUlFINPYRAZONEAPRESAZIDE, HYDRALAZINE HYDROCHLORIDEAPRESOlINE, HYDRALAZINE HYDROCHLORIDEAPRESOlINE-ESIDRIX, HYDRALAZINE HYDROCHLORIDEDESFERAl MESYlATE, DEFEROXAMINE MESYlATEESIDRIX, HYDROCHLOROTHIAZIDEESIMIl, GUANETHIDINE MONOSUlFATEWH, ISONIAZIDISMElIN, GUANETHIDINE SULFATElOCORTEN, FlUMETHASONE PIVAlATEMETA~mREN, METHYLTESTOSTERONEMETOPIRONE, METYRAPONE~~PERCAINE, DIBUCAINE HYDROCHLORIDEPERCORTEN, DESOXYCORTICOSTERONE ACETATEPERCORTEN PIVAlATE, DESOXYCORTICOSTERONE PIVALATEREGITINE. PHENTOLAMINE HYDROCHLORIDEREGITINE, PHENTOLAMINE MESYlATERINACTANE, RIFAMPIN,RITALIN, METHYLPHENIDATE HYDROCHLORIDESER-AP-ES, HYDRALAZINE HYDROCHLORIDESERPASIL, RESERPINESERPASIl-APRESOlINE, HYDRALAZINE HYDROCHLORIDESERPASIl-ESIDRIX #1, HYDROCHLOROTHIAZIDESERPASIl-ESIDRIX #2, HYDROCHLOROTHIAZIDESlOW-K, POTASSIUM CHLORIDEcrs RAD!OI'"A~HSAGGREGATED ALBUMIN (HUMAN) KIT, TECHNETIUM, TC-99M, ALBUMINAGGREGATED KITIODOHIPPURATE SODIUM I 131, IODOHIPPURATE SODIUM. 1-131SELEtl,ONETHIONINE SE 75, SELENOMETHIONINE. SE-75SODIUM IODIDE I 131, SODIUM IODIDE, 1-131SODIUM PERTECHNETATE TC 99M, SODIUM PERTECHNETATE, TC-99MSODIUM ROSE BENGAL I 131, SOOIUM ROSE BENGAL, 1-131SULFUR COllOID KIT,. TECHNETIUM. TC-99M, SULFUR COllOID KITTECHNETIUM TC 99M DTPA (SN) KIT, TECHNETIUM, TC-99M,PENTETATE KITTECHNETIUM TC 99M SULFUR COllOID, TECHNETIUM, TC-99M, SULFURCOllOID
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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 PRESCRIPTION DRUG
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