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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST58FLUPHENAZINE HYDROCHLORIDETABLET; ORALPROLIXIHFOLATE SODIUMINJECTABLE; INJECTIONFOLVITEBP ER SQUIBB AND SONS 2.5MG * 5MG * IOMG LEDERLE LABS/AM CYAN EQ 5MG BASE/MLIMGTABLET, CONTROLLED RELEASE; ORALPERMITILSCHERINGIMGF LUPREDNISOLONETABLET; ORALALPHADROLUPJOHNFlURANDRENOLIDECREAM"; TOPICALCORDRAN SPDISTA PRODS/LILLYLOTION; TOPICALCORDRAN~ISTA PRODS/LILLYOINTHENT; TOPICALCORDRANDISTA PRODS/LILLYTAPE; TOPICALCORDRANDISTA PRODS/LILLYFLURAZEPAM HYDROCHLORIDECAPSULE; ORALDALHANEROCHE PRODUCTSI.5MG0.025/. * O.05/.O.OS/.0.025? * O.OS/.4 UGH/SQ CMISMG * 30HGFOLIC ACIDTABLET; ORAL~OLIC ACIDAA ANABOLIC IMGAA BOLAR PHARM INGAA CHELSEA LABS INGAA DANBURY PHARMACAL INGAA ELI LILLY INGAA GENERIC PHARM/IVY INGAA HALSEY DRUG lNGAA ICN PHARMS INGAA LANNETT INGAA MK LABS ING,AA PHOENIX LABS INGAA PREMO PHARM LABS INGAA PRIVATE FORMULATIONS INGAA PUREPAC PHARM INGAA RICHLYN LABS INGAA STAN LABS PHARM INGAA TABLICAPS INGAA TOWNE PAULSEN ING250 UGMAA WEST-WARD INGAA ZENITH LABS INGAA~OLVITELEDERLE LABS/AM CYAN INGFOLIC ACID; *HULTIPLE*SEE ASCORBIC ACID; FERROUS GLUCONATE; FOLIC ACIDSEE FERROUS SULFATE; FOLIC ACIDFURAZOLIDONESUSPENSION; ORALFUROXONENORWICH-EATON PHARHSOHG/15HL
APPROVED ¥RESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST59FURAZOLIDONETABLET; ORALFUROXONENORWICH-EATON PHARMFUROSEMIDElOOMGINJECTABLE; INJECTIONFUROSEMIDEAP INT'L MEDICATION SYS lOMG/MLLASIXAP HOEC~ST-ROUSSEL lOMG/MLGENTAMICIN SULFATEINJECTABLE; INJECTIONGARAMYCINSCHERINGOINTMENT; TOPICALGARAMYCINSCHERINGEQ 2MG BASE/ML * EQ lOMG BASE/ML *EQ 40MG BASE/MLEQ lMG BASE/GMSOLUTION/DROPS; OPHTHALMICGARAMYCINSCHERINGEQ 3MG BASE/MLSOLUTION; ORALLASIXHOECHST-ROUSSELTABLET; ORALLAS IXHOECHST-ROUSSELGALLAMINE TRIETHIODIDElOMG/ML20MG * 40MG * BOMGINJECTABLE; INJECTIONFLAXEDILDAVIS & GECK/AM CYAN 20MG/ML * lOOMG/MLGALLIUM CITRATE, GA-67GENTIAN VIOLETSUPPOSITORY; VAGINALGVSSAVAGE/BYK-GULDENTAMPON; VAGINALGENAPAXKEY PHARMSGLUCAGON HYDROCHLORIDEINJECTABLE; INJECTIONGLUCAGONELI LILLY0.47.5MGlMG/AMP * lOMG/AMPINJECTABLE; INJECTIONGALLIUM CITRATE GA 67DIAGNOSTIC ISOTOPESBS MALLINCKRODTBS NEW WGLAND NUCLEARNEOSCANBS MEDI-PHYSICSGENTAMICIN SULFATECREAM; TOPICALGARAMYCINSCHERINGlMCI/ML2MCI/ML2MCI/ML2MCI/MLEQ lMG BASE/GMGLUTETHIMIDECAPSULE; ORALOORIDENUSV DEV/PRTABLET; ORALDORIDEHAA USV DEV/PRGLUTETHIMIDEAA CHELSEA LABSAA CORD LABS500MG2S0MG IESOOMGSOOMGSOOMG
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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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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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