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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST92NAFCILLIN SODIUM MONOHYDRATETABLET; ORALHALLPEHAS BEECHMI LABSUHIPEHAB WYETH LABS/AMHONALBUPHINE HYDROCHLORIDEINJECTABLE; INJECTIONNUBAINENDO LABS/DUPONTNALIDIXIC ACIDSUSPENSION; ORALNEGGRAMWINTHROP L/STERLINGTABLET; ORALNEGGRAMEQ SOOMG BASEEg SOOMG BASEIOMG/ML2S0MG/SMLNAPROXENTABLET; ORALNAPROSYNSYNTEX P RNATAMYCINSUSPENSION/DROPS; OPHTHALMICNATACYNALCON LABS S7.NEGATOLSOLUTION; TOPICAL, VAGINALNEGATANSAVAGE/BYK-GULDEN 4S7.NEOMYCIN SULFATEINJECTABLE; INJECTIONWINTHROP LISTER LING 2S0MG * SOOMG * IGM MYCIFRADIHNALOXONE HYDROCHLORIDEINJECTABLE; INJECTIONNARCANENDO LABS/DUPONTNARCAN NEONATALENDO LABS/DUPONTNAPHAZOLINE HYDROCHLORIDESOLUTION/DROPS; OPHTHALMICALBALOHAT ALLERGAN PHARMS O.l?HAPHAZOL!HE HCLAT MAURRY BIOLOGICAL O.l?HAPHCOH FORTEAT ALCON LABS D.l?VASOCOHAT SMITH MILLER PATCH O.l?400 UGM/ML20 UGM/MLAPAPAPAAAAAAUPJOHNHEOMYCIH SULFATEER SQUIBB AND SONSPFIZER LABSOINTMENT; OPHTHALMICMYCIGUENTUPJOHN2S0MG * 37SMGEQ 3S0MG BASE/VIALEg 3S0HG BASE/VIALEQ 350MG BASE/VIALEQ 3.SMG BASE/GMPOWDER; FOR RX COMPOUNDINGHEO-RXPHARMA-TEKEQ lOOGM BASE/BOTEQ lOGH BASE/BOT * EQ SOGM BASE/BOTHEOMYCIH SULFATEELKINS-SINN/AHROBINS EQ lOOGM BASE/BOTUPJOHNEQ lOOGH BASE/BOTSOLUTION; ORALMYCIFRADINUPJOHNEQ 87.5MG BASE/SMLTABLET; ORALMYCIFRADIHAA UPJOHN EQ 3SDMG BASE
"~''''''-- .APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST93NEOMYCIN SULFATETABLET; ORALHEOBl:OTJ:CAA PFIZER LABSHEOMYCJ:H SULFATEE9 3S0MG BASEAA BIOCRAFT LABS E9 3S0MG BASEAA ELI LILLY E9 3S0MG BASEAA ER SQUIBB AND SONS E9 3S0MG BASEAA LANNETT E9 3S0MG BASEAA LEDERLE LABS/AM CYAN Eg 3S0MG BASEAA PHILIPS ROXANE LABS Eg 3S0MG BASEAA VITARINE/WEST CHEM EQ 350MG BASENEOMYCIN SULFATE; *MULTIPLE*SEE ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATESEE BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCINSULFATE; THONlONIUM BROMIDESEE GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATESEE HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATENEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT; OPHTHALMICSTATROLALCON LABSEQ 3.SMG BASE/GM;6,OOO UNITS/GMSOLUTION; IRRIGATIONNEOSPORIN G.U. IRRIGANTBURROUGHS WELLCOME EQ 40MG BASE/ML;200,OOO UNITS/MLSOLUTION/DROPS; OPHTHALMICPOLYSPECTRINALLERGAN PHARMS EQ 0.3SX BASEiS,OOO UNITS/MLSTATROLALCON LABS.EQ 3.5MG BASE/ML;16,2S0 UNITS/MLNEOSTIGMINE BROMIDESOLUTION/DROPS; OPHTHALMICPROSTIGMIN BROMIDEHOFFMANN-LA ROCHE SXNIACINCAPSULE; ORALWAMPOCAPWALLACE LABS/C-WSOOMGTABLET; ORALHl:ACIHAA BOLAR PHARM SOOMGAA CHELSEA LABS S'OOMGAA CORD LABS SOOMGAA DANBURY PHARMACAL SOOHG.AA GENERIC PHARM/IVY SOOMG.AA HALSEY DRUG. SOOMG;AA LEDERLE LABS/AM CYAN SOOMGAA MK LABS SOOMGAA MYLAN PHARMS SOOHGAAAAPUREPAC PHARMRICHLYN LABSSOOMGSOOMGAA STAN LABS PHARM 500MGAA TABLICAPS SOOHGAA WEST-WARD SOOMGAA ZENITH LABS SOOMGHJ:COLARAA ARMOUR PHARM SOOMGNITROFURANTOINCAPSULEi ORALNITROFURANTOINBOLAR PHARMSUSPENSION; ORALFURADANTINNORWICH-EATON PHARMSOMG * 100MG2SMG/SMLTABLET; ORALFIJRADAHTJ:HAS NORWICH-EATON PHARM SOMG M lOOMGFUt:!ALAHAS LANNETT SOMG M lOOMGHl:TROFURAHTOJ:HAB BOLAR PHARM SOMG M lOOMS,;(,,;:~~
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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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