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

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APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX6DEXTROSE 51: AND POTASSIUM CHLORIDE 0.151: IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 51: A~m POTASSIUM CHLORIDE 0.2241: IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X AND POTASSIUM CHLORIDE 0.3X IN PLASTIC CONTAINER.DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE O.llX IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE 0.2X IN PLASTIC CONTAINER,DEXTROS.EDEXTROSE 5X AND SODIUM CHLORIDE 0.225X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE 0.37. IN PLASTIC CONTAINER.DEXTROSEDEXTROSE 57. AND SODIUM CHLORIDE 0.33X IN PLASTIC CONTAINER.DEXTROSEDEXTROSE 5X AND SODIUM CHLORIDE 0.45X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 51: AND SODIUM CHLORIDE 0.9/. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 51: IN ACETATED RINGER'S IN PLASTIC CONTAINER. CALCIUMCHLORIDEDEXTROSE 51: IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUMCHLORIDED~XTROSE 57. IN PLASTIC CONTAINER. DEXTROSEDEXTROSE 5X IN RIN.GER' S IN PLASTIC CONTAINER. CALCIUM CHLORIDEDEXTROSE 5X IN SODIUM CHLORIDE 0.27. IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X IN SODIUM CHLORIDE 0.33X IN PLASTIC CONTAINER.DEXTROSEDEXTROSE 51: IN SODIUM CHLORIDE 0.45X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 5X IN SODIUM CHLORIDE 0.9X IN PLASTIC CONTAINER,DEXTROSEDEXTROSE 57. WI ELECTROLYTE 48 IN PLASTIC CONTAINER. DEXTROSEDEXTROSE 57., SODIUM CHLORIDE 0.2X AND POTASSIUM CHLORIDE0.075X, DEXTROSEDEXTROSE 5X, SODIUM CHLORIDE 0.27. AND POTASSIUM CHLORIDE 0.15X,DEXTROSEDEXTROSE 5X, SODIUM CHLORIDE 0.2X AND POTASSIUM CHLORIDE0.2247., DEXTROSEDEXTROSE 57., SODIUM CHLORIDE 0.27. AND POTASSIUM CHLORIDE 0.37.,DEXTROSEDEXTROSE 5X, SODIUM CHLORIDE 0.225X AND POTASSIUM CHLORIDE0.15X, DEXTROSEDEXTROSE 57., SODIUM CHLORIDE 0.457. AND POTASSIUM CHLORIDE0.157., DEXTROSEDEXTROSE 5X, SODIUM CHLORIDE 0.45X AND POTASSIUM CHLORIDE0.224X, DEXTROSEDEXTROSE 5X, SODIUM CHLORIDE 0.457. AND POTASSIUM CHLORIDE0.075X, DEXTROSEDEXTROSE S7., SODIUM CHLORIDE 0.4S7. AND POTASSIUM CHLORIDE 0.37.,DEXTROSEDEXTROSE 50X IN PLASTIC CONTAINER, DEXTROSEDEXTROSE 60X, DEXTROSEDI-ATRO, ATROPINE SULFATEDI-METREX, PfiENDIMETRAZINE TARTRATEDIABINESE, CHLORPROPAtlIDEDIAFEN HCL, DIPHENYLPYRALINE HYDROCHLORIDEDIAGNEX BLUE, AZURESINDIAL, HEXACHLOROPHENEDIAMOX, ACETAZOLAMIDEDIAMOX, ACETAZOLAMIDE SODIUMDIANEAL 137 WI DEXTROSE 1.5X IN PLASTIC CONTAINER, CALCIUMCHLORIDEDIANEAL 137 WI DEXTROSE 2.5X IN PLASTIC CONTAINER, CALCIUMCHLORIDEDIANEAL 137 WI DEXTROSE 4.25X IN PLASTIC CONTAINER, CALCIUMCHLORIDEDIAPID, LYPRESSINDIASONE SODIUM, SULFOXONE SODIUMDIATRIZOATE MEGLUMINE, DIATRIZOATE MEGLUMINEDIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDEDICOPAC KIT, CYANOCOBALAMINDICUMAROL, BISHYDROXYCOUMARINDICURIN PROCAINE, PROCAINE MERETHOXYLLINEDIDREX, BENZPHETAMINE HYDROCHLORIDEDIDRCNEL. ETIDRONATE DISODIUMDIENESTROL, DIENESTROLDIETHYLPROPION HCL, DIETHYLPROPION HYDROCHLORIDEDIETHYLSTILBESTROL, DIETHYLSTILBESTROLDIGOXIN, DIGOXINDIHYDROERGOTOXINE MESYLATE, DIHYDROERGOCORNINE MESYLATEDIHYDROERGOTOXINE METHANESULFONATE, DIHYDROERGOCORNINE MESYLATEDILANTIN, PHENYTOINDILANTIN, PHENYTOIN SODIUMDILANTIN-125. PHENYTOINDILANTIN-30, PHENYTOINDILOR, DYPHYLLINEDILOR-400, DYPHYLLINEDIMENHYDRINATE, DIMENHYDRINATEDIMERAY, IOCARMATE MEGLUMINEDIMETANE, BRO~IPHENIRAMINE MALEATEDIMETANE-TEN, BROMPHENIRAMINE MALEATEDIONOSIL AQUEOUS. PROPYLIODONEDIONOSIL OILY. PROPYLIODONEDIPAXIN. DIPHENADIONEDIPHEN, DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDEDIPHENOXYLATE HCL AND ATROPINE SULFATE, ATROPINE SULFATEDIPHENOXYLATE HCL WI ATROPINE SULFATE, ATROPINE SULFATEDIPHENOXYLATE WI ATROPINE SULFATE, ATROPINE SULFATE
APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX7DIPHENYLAN SODIUM, PHENYTOIN SODIUMDIPROSONE, BETAMETHASONE DIPROPIONATEDISIPAL, ORPHENADRINE HYDROCHLORIDEDISODIUM EDETATE. EDETATE DISODIUMDISOMER, DEXBROMPHENIRAMINE MALEATEDITATE-DS, ESTRADIOL VALERATEDITROPAN, OXYBUTYNIN CHLORIDEDIUCARDIN, HYDROFLUMETHIAZIDEDIUPRES-250, CHLOROTHIAZIDEDIUPRES-500, CHLOROTHIAZIDEDIURIL, CHLOROTHIAZIDEDIURIL, CHLOROTHIAZIDE SODIUMDIUTENSEN-R, HETHYCLOTHIAZIDEDOBUTREX, DOBUTAHINE HYDROCHLORIDEDOCA, DESOXYCORTICOSTERONE ACETATEDODEX, CYANO,COBALAMINDDLENE, PROPDXYPHENE HYDROCHLORIDEDOLENE AP-65~ ACETAHINOPHENDOLENE CO~IPOUND-65, ASPIRINDOLOPHINE HCL, METHADONE HYDROCHLORIDEDOMEBORO, ACETIC ACID, GLACIALDOPAR, LEVODOPADOPRAH, DOXAPRAM HYDROCHLORIDEDORIDEN, GLUTETHIMIDEDORMATE, MEBUTAtlATEDORSACAINE, BENOXINATE HYDROCHLORIDEDOW-ISONIAZID, ISONIAZIDDOXYCHEL, DOXYCYCLINE MONOHYDRATEDOXYCHEL HYCLATE, DOXYCYCLINE HYCLATEDRALSERP, HYDRALAZINE HYDROCHLORIDEDRALZINE, HYDRALAZINE HYDROCHLORIDEDRAMAtlINE,' DIMENHYDRINATEDRICORT, HYDROCORTISONE ACETATEDRISDOL, ERGOCALCIFEROLDRIXORAL, DEXBRotlPHENIRAMINE MALEATEDROLBAN, DROHOSTANOLONE PROPIONATEDTIC-DOME, DACARB.4ZINEDTPA (SN) KIT (CHELATE), TECHNETIUM, TC-99M, PENTETATE KITDUO-~IEDIHALER., ISOPROTERENOL HYDROCHLORIDEDUPHASTON, DYDROGESTERONEDURA-LUTIN, HYDROXYPROGESTERONE CAPROATEDURACIlLIN A.S., PENICILLIN G PROCAINEDURANEST, ETIDOCAINE HYDROCHLORIDEDURANEST WI EPINEPHRINE, EPINEPHRINEDURAQUIN, QUINIDINE GLUCONATEDURICEF, CEFADROXIL MONOHYDRATEDUVOID, BETHANECHOL CHLORIDEDV, DIENESTROLDYAZIDE, HYDROCHLOROTHIAZIDEDYCILL, DICLOXICILLIN SODIUM MONOHYDRATEDYCLONE, DYCLONINE HYDROCHLORIDEDYMELOR, ACETOHEXAMIDEDYNAPEN, DICLOXICILLIN SODIUM MONOHYDRATEDYRENIUM, TRIAMTERENE** E **E.E.S., ERYTHROMYCIN ETHYLSUCCINATEE.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATEE.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATEE-MYCIN, ERYTHROMYCINE-MYCIN E, ERYTHROMYCIN ETHYLSUCCINATEE-Z SCRUB SURGICAL, ALKYL AMMONIUM SULFONIC ACID BETAINE(SULFOBETAINE DEH)ECHODIDE, ECHOTHIOPHATE IODIDEECONOCHLOR, CHLORAMPHENICOLECONOPRED, PREDNISOLONE ACETATEECONOPRED PLUS, PREDNISOLONE ACETATEEDECRIN, ETHACRYNATE SODIUMEDECRIN, ETHACRYNIC ACIDEDETATE DISODIUM, EDETATE DISODIUMEFUDEX, FLUOROURACILELASE WI CHLOROMYCETIN, CHLORAMPHENICOLELAVIL, AMITRIPTYLINE HYDROCHLORIDEELDECORT, HYDROCORTISONEELIXOPHYlLIN, THEOPHYlLINEEMETE-CON, BENZQUINAMIDE HYDROCHLORIDEEMPRACET WI CODEINE PHOSPHATE #3, ACETAMINOPHENEMPRACET WI CODEINE PHOSPHATE #4, ACETAMINOPHENENDEP, AMITRIPTYLINE HYDROCHLORIDEE~IDRATE, EDETATE DISODIUMENDURON, METHYCLOTHIAZIDEENDURONYL, DESERPIDINEENDURONYL FORTE, DESERPIDINEENOVID, MESTRANOLENOVID-E, MESTRANOLENOVID-E 21, MESTRANOLEPICORT, HYDROCORTISONEEPIFOAM, HYDROCORTISONE ACETATEEQUAHIL, MEPROBAMATEEQUIPIN, HOMATROPINE METHYLBROMIDEERYPAR, ERYTHROMYCIN STEARATEERYTHROCIN LACTOSIONATE, ERYTHROMYCIN LACTOBIONATEERYTHROCIN STEARATE, ERYTHROMYCIN STEARATEERYTHROMYCIN, ERYTHROMYCINERYTHROMYCIN ESTOLATE,' ERYTHROMYCIN ESTOLATEERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE'ERYTHROMYCIN STEARATE, ERYTHROMYCIN STEARATEESCABIOL, LINDANEESIDRIX, HYDROCHLOROTHIAZIDEESIMIL, GUANETHIDINE MOHOSULFATEESKALITH, LITHIUM CARBONATE
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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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DIMENHYDlHNATEAPPROVED PRESCRIPTION
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------"".,APPROVED PRESCRIPTION DRU
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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