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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST94NITROFURANTOINNITROFURAZONETABLET; ORALH:tTROFURAHTOIHAB CHELSEA LABSAB FEDERAL PHARMACALAB KETCHUM LABSAB TOWNE PAULSENAB ZENITH LABSNITROFURANTOIN SODIUMSOMG * lOOMG2Q!1§ * illtl§SOHG * lOOHGSOMG IE lOOHGSOHG * 100MGSOLUTION; TOPICALNITROFURAZONECLAY-PARK LABSNORETHINDRONETABLET; ORALNOR-Q.D.SYNTEX(F P)NOR LUTINPARKE-DAVISIW-LINJECTABLE; INJECTIONIVADANTINNORWICH-EATON PHARM EQ l80MG BASE/VIAL TABLET; ORAL-28MICRONORORTHO PHARMNITROFURANTOIN, MACROCRYSTALLINECAPSULE; ORALHACRODANTINNORWICH-EATON PHARMINITROFURAZONECREAM; TOPICALFURACINNORWICH-EATON PHARM 0.2?DRESSING; TOPICALACTIH-HAT CHESEBROUGH-PONDSFURACIHO.2~AT NORWICH-EATON PHARM O.2~HITROFURAZOHEAT MALLARD O.2~AT SHAFFER-DAVIS LABS ~OINTMENT; TOPICALHITROFURAZOHEAT ANBIX LABS/ORGANICS 0.2~AT CLAY-PARK LABS O.2~AT LANNETT O.2~POWDER; TOPICALFURACINNORWICH-EATON PHARM 0.27.25MG * SONG * IOOMGNORETHINDRONE ACETATETABLET; ORALNORLUTATEPARKE-DAVIS/W-L0.27.350 UGM5MG350 UGMSMGNORETHINDRONE ACETATE; *MULTIPLE*SEE ETHINYL ESTRADIOL; NORETHINDRONE ACETATESEE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE; FERROUSFUMARATENORETHINDRONE; *MULTIPLE*SEE ETHINYL ESTRADIOL; NORETHINDRONESEE MESTRANOL; NORETHINDRONENORETHYNODREL; *MULTIPLE*SEE MESTRANOL; NORETHYNODRELNORGESTRELTABLET; ORALOVRETTEWYETH LABS/AMHO75 UGM
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST95NORGESTREL; *MULTIPLE*SEE ETHINYL ESTRADIOL; NORGESTRELSEE ETHINYL ESTRADIOL; NORGESTREL; FERROUS FUMARATENORTRIPTYLINE HYDROCHLORIDECAPSULE; ORALAVENTYL HCLBP ELI LILLYPAMELORBP SANDOZ PHARMSSOLUTION·; ORALAVEHTYL HCLAA ELI LILLYPAHELORAA SANDOZ PHARMSNOVOBIOCIN CALCIUMSYRUP; ORALALBAMYCINUPJOHNNOVOBIOCIN SODIUMCAPSULE; ORALALBAMYCINUPJOHNINJECTABLE; INJECTIONALBAHYCINUPJOHNNYSTATINEQ 10MG BASE * EQ 25MG BASEEQ 10MG BASE * EQ 25MG BASEEQ SOMG BASE * EQ 75MG BASEEQ 10MG BASE/5MLEQ 10HG BASE/5HLEQ 125MG BASE/5MLEQ 250MG BASEEQ 500MG BASE/VIALCREAM; TOPICAL!l.AHDEXAT DOME LABS/MILES LABS 100.000 UHJ:TS/GMMYCOSTATJ:HAT ER SQUIBB AND SONS 100,000 UHJ:TS/GHNYSTATINCREAM; TOPICALHILSTATAT LEDERLE LABS/AM CYAN 100,000 UHITS/GHHYSTATINAT BYK-GULDEN 100,000 UHITS/GHAT CLAY-PARK LABS 100,000 UHITS/GHAT PREMO PHARM LABS 100,000 UHITS/GHLOTION; TOPICALCANDEXDOME LABS/MILES LABS 100,000 UNITS/MLOINTMENT; TOPICALHYCOSTATIHAT ER SQUIBB AND SONS 100,000 UHITS/GHHILS TATAT LEDERLE LABS/AM CYAN 100,000 UHITS/GHHYSTATIHAT PREMO PHARM LABS 100.000 UHITS/GMAAAAAAAAAAATPOWDER; TOPICALMYCOSTATINER SQUIBB AND SONSSUPPOSITORY; VAGINALNYSERTNORWICH-EATON PHARM100,000 UNITS/GM100,000 UNITSSUSPENSION; ORALMYCOSTATIHER SQUIBB AND SONS 100:000 UHITS/MLHILSTATLEDERLE LABS/AN CYAN 100,000 UHITS/NLTABLET; ORALMYCO!i?TATIHER SQUIBB AND SONS 500,000 UHITSHJ:LSTATLEDERLE LABS/AM CYAN 500.000 UHJ:TSHYSTATIHPREMO PHARM LABSTABLET; VAGINALKOROSTATIHHOLLAND-RANTOS500,000 UHJ:TS100,000 UNITS
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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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PERCORTEN PIVALATE, DESOXYCORTICOST
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oAPPROVED PRESCRIPTION DRUG PRODUCT
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APPROVED PRESCRIPTIOH DRUG PRODUCTS
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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