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

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APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX14ER !;gUT.B'3 Mill SOilSALBmlOTOPE 125 I, ALBUMIN, IODINATED, L-125, SERUMALBUMOTOPE 131 I, ALBUMIN, IODINATED, 1-131, SERUMAMITID, AMITRIPTYLINE HYDROCHLORIDEAMNESTROGEH, ESTROGENS, ESTERIFIEDCARDIOSRAFIN, DIATRIZOATE MEGLUMINECHLORMERODRIN HG 197, CHLORtlERODRIN, HG-197CHO:"OGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINECHOLOGRAFIN SODIUM, IODIPAMIDE SODIUMCHROMALBIN, ALBUMIN, CHROMATED, CR-51, SERUMCHROMITOPE SODIUM, SODIUM CHROMATE, CR-51CORGARD, NADOLOLCYSTOGRAFIN, DIATRIZOATE MEGLUMINEDELADUHONE, ESTRADIOL VALERATEDELADUflONE OB, ESTRADIOL VALERATEDELALUTIN, HYDROXYPROGESTERONE CAPROATEDELATESTRYL, TESTOSTERONE ENANTHATEDELESTROGEN, ESTRADIOL VALERATEDIAGNEX BLUE, AZURESINDIATRIZOATE MEGLUMINE, DIATRIZOATE MEGLUMINEETHRIL 250, ERYTHRot1YCIN STEARATEETHRIL 500, ERYTHROMYCIN STEARATEFLORIliEF, FLUDROCORTISONE ACETATEFOLLUTEIN, GONADOTROPIN, CHORIONICFUNGIZOIlE, AMPHOTERICIN BGASTROGRAFW, DIATRIZO.UE MEGLUMINEHALCIDERM, HALCINONIDEHALOG, HALCINONIDEHIPPUTOPE, IODOHIPPURATE SODIUM, 1-131HYDREA, HYDROXYUREAIODOTOPE, SODIUM IODIDE, 1-131KENACORT, TRIAMCINOLOIlEKENACORT, TRIA~ICIIiOLONE DHCETATEKENALOG, TRIAMCINOLOIlE ACETONIDEKENALOG IN ORABASE, TRIAMCINOLONE ACETONIDEKEN.ALOG-H, TRIAMCII\OLGNE ACETOIUDEKENALOG-I0, TRIAMCINOLONE ACETONIDEKENALOG-40, TRIAMCINOLONE ACETONIDEKINEVAC, SINCALIDEMACROTEC, TECHNETIUM, TC-99M, ALBUMIN AGGREGATED KITMINITEC, TECHNETIUM, TC-99M GENERATOR/SODIUM PERTECHNETATE,TC-99M~IYCOSTATIN,NYSTATINNATURETIN-I0, BENDROFLU~IETHIAZIDENATURETIN-2.5, BENDROFLUtlETHIAZIDENATURETIN-5, BENDROFLmlETHIAZIDENEotlYCIN SULFATE, NEOMYCIN SULFATENYDRAZID, ISONIAZIDOPHTHAINE, PROPARACAINE HYDROCHLORIDEORA-TESTRYL, F LUOXnlESTERONEORAGRAFIN CALCIUM, CALCIUl1 IPODATEORAGRAFIN SODIUM, IPODATE SODIUMER SOU!~BAW) SOH;PENICILLHl G POTASSIUM, PENICILLIN G POTASSIUMPENTIDS '200', PENICILLIN G POTASSIUMPENTIDS '250', PENICILLIN G POTASSIUMPENTIDS '400', PENICILLIN G POTASSIUMPENTIDS '800', PENICILLIN G POTASSIUMPHOSPHOTEC, TECHNETIUM, TC-99M, PYROPHOSPHATE KITPHOSPHOTOPE, SODIUM PHOSPHATE, P-32PRINCIPEN '125', AMPICILLIN/AMPICILLIN TRIHYDRATEPRINCIPEN '250', AMPICILLIN/AMPICILLIN TRIHYDRATEPRINCIPEN '500', AMPICILLIN/AMPICILLIN TRIHYDRATEPRINCIPEN 14/ PROBENECID, AMPICILLIN TRIHYDRATEPROLIXIN, FLUPHENAZINE HYDROCHLORIDEPROLIXIN DECANOATE, FLUPHENAZINE DECAt~OATEPROLIXIN ENANTHATE, FLUPHENAZINE ENANTHATEPRONESTYL, PROCAINAMIDE HYDROCHLORIDERAU-SED, RESERPINERAUDIXHl, RAUWOLFIA SERPENTINARENO-M-DIP. DIATRIZOATE NEGLU11INERENO-M-30. DIATRIZOATE MEGLUMINERENO-M-60. DIATRIZOATE MEGLUMINERENOGRAFIN-60, DIATRIZOATE NEGLUMINERENOGRAFIN-76, DIATRIZOATE MEGLUMINERENOTEC, TECHNETIUM, TC-99M, PENTETATE KITRHiOVIST, DIATRIZOATE MEGLUNINERENOVIST II, DIATRIZOATE MEGLUMINERENOVUE-DIP, IODAMIDE MEGLUMINERENOVUE-65, IODAMIDE MEGLU~IINEREZIPAS, AMINOSALICYLIC ACID RESIN COMPLEXROBENGATOPE, SODIUM ROSE BENGAL, 1-131RUBRAt1IN-PC, CYANOCOBALAMINRUSRATOPE-57, CYANOCOBALAMIN, CO-57RUBRATOPE-57 KIT, COBALT CHLORIDE, CO-57RUBRATOPE-60, CYANOCOBALAMIN, CO-60RUBRATOPE-60 KIT, COBALT CHLORIDE, CO-60SETHOTOPE, SELENCMETHIONINE, SE-75SINCGRAFII~, DIATRIZOATE NEGLUNINESTILBESTROL, DIETHYLSTILBESTROLSUCOSTRIN, SUCCINYLCHOLINE CHLORIDESUHYCIN, TETRACYCLIIlESUMYCIN, TETRACYCLINE HYDROCHLORIDETERFONYL, TRISULFAPYRIMIDINESTESLAC, TESTOLACTONETESULOID, TECHNETIUI1, TC-99M, SULFUR COLLOID KITTRIMOX, ANOXICILLIN TRIHYDRATETUSOCURARWE CHLORIDE, TUSOCURARINE CHLORIDEVEETIDS '125', PENICILLIN V POTASSIUMVEETIDS '250', PENICILLIN V POTASSIUMVEETIDS '500', PENICILLIN V POTASSIUMVELOSEF, CEPHRADINEVESPRIH, TRIFLUPROMAZINE HYDROCHLORIDEVESPRIN HIGH POTENCY, TRIFLUPROMAZINE
--~.~/APPROVED PRESCRIPTION DRUG PRODUCTSAPPLICATION HOLDER INDEX15ER S:WrElB AHD ~r:msVITAMIN A, VITAMIN A PALMITATEEr
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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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