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

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APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX12MENEST, ESTROGENS, ESTERIFIEDMENRIUN 10-4, CHLORDIAZEPOXIDEMENRIUM 5-2, CHLORDIAZEPOXIDE~1ENlnUM 5-4, CHLORDIAZEPOXIDEMEPERGAN, MEPERIDINE HYDROCHLORIDEMEPERIDINE I,ND ATROPINE SULFATE, ATROPINE SULFATEMEPERIDINE HCL, MEPERIDINE HYDROCHLORIDEMEPHYTON, PHYTONADIONEMEPIVACAINE HCL, MEPIVACAINE HYDROCHLORIDEMEPIVACAINE HCL W/ LEVONORDEFRIN, LEVONORDEFRINMEPRIAM, rlEPROBAMATEMEPROBAMATE, MEPROBAMATEMEPROSPAN, MEPROBAMATEMERSALYL-THEOPHYLLINE, MERSALYL SODIUMMESANTOIN, MEPHENYTOINMESTINON, PYRIDOSTIGMINE BROMIDEMETAHYDRIN, TRICHLORMETHIAZIDEMETANDREN, METHYLTESTOSTERONEMETARAMINOL BITARTRATE, METARAMINOL BITARTRATEMETATENSIN 2, RESERPINEMETATENSIN 4, RESERPINEMETHADONE HCL, METHADONE HYDROCHLORIDEMETHADOSE, METHADONE HYDROCHLORIDE~1ETHAMPEX, ~1ETHAMPHETAMINE HYDROCHLORIDEMETHAMPHETAMINE HCL, METHAMPHETAMINE HYDROCHLORIDEMETHERGINE, METHYLERGONOVINE MALEATEMETHOCARBAMOL, METHOCARBAMOLMETHOSARB, CALUSTERONEMETHOTREXATE, METHOTREXATEMETHOTREXATE, METHOTREXATE SODIUMMETHSCOPOLAMINE BROMIDE, METIISCOPOLAt1INE BROMIDEMETHYLPHENIDATE HCL, METHYLPHENIDATE HYDROCHLORIDEMETHYlPREDISOLONE ACETATE, METHYlPREDNISOLONE ACETATEMETHYLPREDNISOLONE, METHYLPREDNISOLONEMETHYlPREDNISOLONE, METHYlPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATEMETHYLTESTOSTERONE, METHYLTESTOSTERONEMETI-DERN, ALUMINUM CHLORHYDROXY ALLANTIONATEMETICORTELONE ACETATE, PREDNISOLONE ACETATEMETICORTEN, PREDNISONENETOPIRONE, METYRAPONEMETRA, PHENDINETRAZINE TARTRATENETRETON, PREDNISOLONE SODIUM PHOSPHATEMETUBINE IODIDE, METOCURINE IODIDEMEXATE, METHOTREXATE SODIUMNICATIN, NICONAZOLE NITRATEMICRAININ, ASPIRINMICRONOR, NORETHINDRONEMICROSUL, SULFAMETHIZOLEMILONTIN, PHENSUXIHIDEMILPREM-200, ESTROGENS, CONJUGATEDMILPREN-400, ESTROGENS, CONJUGATEDMILTOWN, MEPROBAMATEMINIPRESS, PRAZOSIN HYDROCHLORIDEMINITEC, TECHNETIUM, TC-99M GENERATOR/SODIUM PERTECHNETATE,TC-99MMINIZIDE, POLYTHIAZIDEMWOCIH, MINOCYCLINE HYDROCHLORIDEMINTEZOL, THIABENDAZOLEMIOCHOL, ACETYlCHOLINE CHLORIDEMIOSTAT, CARBACHOLMIRADON, ANISINDIONEMITHRACIN, MITHRAt1YCINMOBAN, MOLINOONE HYDROCHLORIDEMODERIL, RESCINNAHINEMODICON, ETHINYL ESTRADIOLMODICON 28, ETHINYL ESTRADIOLMONISTAT, MICONAZOLEMONISTAT-7, MICONAZOLE NITRATEMOTOFEN, ATROPINE SULFATEMOTOFEN HALF-STRENGTH, ATROPINE SULFATEMOTRIN, IBUPROFENMPI KRYPTON 81M GAS GENERATOR, KRYPTON, KR-81MMPI STA~~lOUSDIPHOSPHONATE, TECHNETIUM, TC-99M, ETIDRONATE KITMUCOMYST, ACETYLCYSTEINEMUCOMYST WI ISOPROTERENOL, ACETYLCYSTEINEMULTIFUGE, PIPERAZINE CITRATEMUSTARGEN, MECHLORETHAMINE HYDROCHLORIDEMUTAMYCIN, MITOMYCIN CMYAMBUTOL, ETHAMBUTOL HYDROCHLORIDEMYCELEX, CLOTRIMAZOLEMYCELEX-G, CLOTRIMAZOLEMYCHEL, CHLORAMPHENICOLMYCHEL-S, CHLORAMPHENICOL SODIUJ1 SUCCINATEMYCIFRADIN, NEOMYCIN SULFATEMYCIGUENT, NEOMYCIN SULFATEMYCITRACIN, BACITRACINMYCOSTATIN, NYSTATINMYDRIACYL, TROPICAMIDEMYLAXEN, HEXAFLUORENIUM BROMIDEMYLERAN, BUSULFAN .MYOTONACHOL, BETHANECHOL CHLORIDEMYSOLINE, PRIMIDONEMYTELASE, AMBENONIUM CHLORIDE** N **NAFCIL, NAFCILLIN SODIUJ1 MONOHYDRATENALFON, FENOPROFEN CALCIUM DIHYDRATENALLPEN, NAFCILLIN SODIUM MONOHYDRATENAPHAZOLINE HCL, NAPHAZOLINE HYDROCHLORIDENAPHCON FORTE, NAPHAZOLINE HYDROCHLORIDE
APPROVED PRESCRIPTION DRUG PRODUCTSTRADE NAME INDEX13NAPROSYN, NAPROXENNAQUA, TRICHLORMETHIAZIDENAQUIVAL, RESERPINENARCAN, NALOXONE HYDROCHLORIDENARCAN NEONATAL, NALOXONE HYDROCHLORIDENARDIL, PHENELZINE SULFATENATACYN; NATAMYCINNATURETIN-10, BENDROFLUMETHIAZIDENATURETIN-2.5, BENDROFLUtlETHIAZIDENATURETIN-5, BENDROFLUMETHIAZIDENAVANE, THIOTHIXENENAVANE, THIOTHIXENE HYDROCHLORIDENEBCIN, TOBRAMYCIN SULFATENEGATAN, NEGATOLNEGGRAM, NALIDIXIC ACIDNEMBUTAL, PENTOBARBITALNEMBUTAL SODIUM, PENTOBARBITAL SODIUMNEO-CORT-DOME, ACETIC ACID, GLACIALNEO-HOMBREOL M, METHYLTESTOSTERONENEO-POLYCIN, BACITRACIN ZINCNEO-POL YCIN, GRAllICIDINNEO-RX, NEOMYCIN SULFATENEOBIOTIC, NEOMYCIN SULFATENEOtlYCIN SULFATE, NEOMYCIN SULFATENEOPASALATE, AtlINOSALICYLIC ACIDNEOSCAN, GALLIUM CITRATE, GA-67NEOSPORIN, BACITRACIN ZINCNEOSPORIN, GRAMICIDINNEOSPORIN G.U. IRP.IGANT, NEOMYCIN SULFATENEOTHYLLINE, DYPHYLLINENEOTRIZINE, TRISULFAPYRIMIDINESNEPHRAMINE 5.4/0, AMINO ACIDSNEPTAZANE, tlETHAZOLAMIDENESACAINE, CHLOROPROCAINE HYDROCHLORIDENESACAINE CE, CHLOROPROCAINE HYDROCHLORIDENEURAMATE, MEPROBAMATENIACIN, NIACINNICALEX, ALUtlINUM NICOTINATE:NICOLAR, NIACINNICONYL, ISONIAZIDNILSTAT, NYSTATINNIPRIDE, SODIUM NITROPRUSSIDENITROFURANTOIN, NITROFURANTOINNITROFURAZONE, NITROFURAZONENOLUDAR, METHYPRYLONNOLVADEX, TAMOXIFEN CITRATENOR-Q.D., NORETHINDRONENOR FLEX, ORPHENADRINE CITRATENORGESIC, ASPIRINNORGESIC FORTE, ASPIRINNORINYL, MESTRANOLNORINYL 1+50 21, MESTRANOLNORINYL 1+50 28, MESTRANOLNORINYL 1+80 21, MESTRANOLNORINYL 1+80 28, MESTRANOLNORISODRINE, ISOPROTERENOL SULFATENORISODRINE AEROTROL, ISOPROTERENOL HYDROCHLORIDENORLESTRIN FE 1/50, ETHINYL ESTRADIOLNORLESTRIN FE 2.5/50, ETHINYL ESTRADIOLNORLESTRIN 21 1/50, ETHINYL ESTRADIOLNORLESTRIN 21 2.5/50, ETHINYL ESTRADIOLNORLESTRIN 28 1/50, ETHINYL ESTRADIOLNOR LUTATE, NORETHINDRONE ACETATENORLUTIN, NORETHINDRONENORMOSOL-M AND DEXTROSE 5/0 IN PLASTIC CONTAINER, DEXTROSENORMOSOL-R AND DEXTROSE 5/0 IN PLASTIC CONTAINER, DEXTROSENORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDENORPACE, DISOPYRAMIDE PHOSPHATENORPRAMIN, DESIPRAMINE HYDROCHLORID~NOVAFED, PSEUDOEPHEDRINE HYDROCHLORIDENOVOCAIN, PROCAINE HYDROCHLORIDENOVRAD, LEVOPROPOXYPHENE NAPSYLATENUBAIN, NALBUPHINE HYDROCHLORIDENUMORPHAN HCL, OXYMORPHONE HYDROCHLORIDENUPERCAINE, DIBUCAINE HYDROCHLORIDENUTRACORT, HYDROCORTISONENYDRAZID, ISONIAZIDNYSERT, NYSTATINNYSTAFORM, IODOCHLORHYDROXYQUINNYSTATIN, NYSTATIN** 0 **OCUSERT PILO-20, PILOCARPINEOCUSERT PILO-40, PILOCARPINEOGEN, PIPERAZINE ESTRONE SULFATEOHNIPEN (AMPICILLIN), AMPICILLIN/AMPICILLIN TRIHYDRATEOMNIPEN N, AI1PICILLIN SODIUMONA MAST, PHENTERMINE HYDROCHLORIDEONCOVIN, VINCRISTINE SULFATEOPHTHAINE, PROPARACAINE HYDROCHLORIDEOPHTHETIC, PROPARACAINE HYDROCHLORIDEOPHTHOCHLDR, CHLORAMPHENICOLOPTEF, HYDROCORTISONEOPTIMINE, AZATADINE MALEATEORA-TESTRYL, FLUOXYMESTERONEORABASE HCA, HYDROCORTISONE ACETATEORAGRAFIN CALCIUM, CALCIUM IPODATEORAGRAFIN SODIUM, IPODATE SODIUMORASONE, PREDNISONEORATROL, DICHLORPHENAMIDEORETIC, HYDROCHLOROTHIAZIDE
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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 PROD
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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