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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST86METHARBITAlTABLET; ORALGEMONIlABBOTT LABSMETHAZOLAMIDElOOMGMETHICILLIN SODIUM MONOHYDRATEINJECTABLE; INJECTIONSTAPHCILlIHAP " BRISTOL LABS/BMAPAPEQ 900MG BASE/VIAL *Eg 3.6GM BASE/VIAL *Eg 5.4GM BASE/VIALTABLET; ORALNEPTAZANELEDERLE LABS/AM CYAN 50MGMETHDILAZINE HYDROCHLORIDESYRUP; ORALTACARYlWESTWOOD PHARMSTABLET; ORALTACARYlWESTWOOD PHARMSTABLET, CHEWABLE; ORALTACARYlWESTWOOD PH ARMSMETHENAMINE HIPPURATE4MG/5MLSMG3.6MGTABLET; ORALHIPREXA8 MERRELL-NATIONALUREXIGMAB RIKER LABS/3M IGMMETHICILLIN SODIUM MONOHYDRATEINJECTABLE; INJECTIONCElBEHIHAP BEECHAM LABSAPAPEQ 900MG BASE/VIAL *Eg 3.6GM BASE/VIAL *Eg 5.4GM BASE/VIALEQ 1.SGM BASE/VIAL *EQ 9GM BASE/VIALMETHIMAZOLETABLET; ORALTAPAZOLEELI LILLYMETHIXENE HYDROCHLORIDETABLET; ORALTRESTDORSEY LABS/SANDOZMETHOCARBAMOLINJECTABLE; INJECTIONMETHOCARBAMOlAP CARTER-GLOGAURCBAXIHAP AH ROBINSTABLET; ORALDElAXIHAA FERNDALE LABSFORBAXIHAA FOREST LABSMETHOCARBAMOlAA BARR LABSAA BOLAR PHARMAA CHELSEA LABSAA CORD LABSAA DANBURY PHARMACALAA GENERIC PHARM/IVYAA HEATHER DRUGAA INWOOD LABS/FORESTAA KV PHARMACEUTICAL5MG If lOMGIMGlOOMG/MllOOMG/Ml500MG750MG500MG * 750MG500MG * 750MG500MG * 750MG500MG * liQtl§500MG * 750MG500MG * 750MG500MG * 750MG500MG500MG * 750MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST87METHOCARBAMOLTABLET; ORALMETHOCA~BAMOLAA LANNETT 750MGAA LEDERLE LABS/AM CYAN 500MG M 750MGAA MYLAN PH ARMS 500MG M 750MGAA PAR PHARM500MG M 750MGAA PUREPAC PHARM 500MG M 750MGAA REID-PROVIDENT LABS 500MG M 75mlGAA RICHLYN LABS500MG M 750MGAA TABLICAPS500MG M 750MGAA WEST-WARD500MG M 750MGAA ZENITH LABS500MG M 750MGROBAX:IHAA AH ROBINS500MG M 750MGMETHOCARBAMOL; *MULTIPLE*SEE ASPIRIN; METHOCARBAMOLMETHOHEXITAL SODIUMINJECTABLE; INJECTIONBREVITAL SODIUMELI LILLYMETHOTREXATETABLET; ORALMETHOTREXATELEDERLE LABS/AM CYAN 2.5MGMETHOTREXATE SODIUMINJECTABLE; INJECTIONMETHOTREXATEAP LEDERLE LABS/AM CYANAPAPAPMEXATEBRISTOL LABS/BM500MG/AMP * 2.5GM/AMP * 5GM/AMPE~ 20MG BASE/V:IAL ME~ 50MG BASE/V:IALEQ 2.5MG BASE/ML * EQ 25MG BASE/ML *EQ 5MG BASE/VIALE~ 20MB BASE/V:IAL *EQ 50MG BASE/V:IALMETHOTREXATE SODIUMINJECTABLE; INJECTIONMEXATEBRISTOL LABS/BMMETHOTRIMEPRAZINEINJECTABLE; INJECTIONLEVOPRotlELEDERLE LABS/AM CYAN 20MG/MLMETHOXAMINE HYDROCHLORIDEINJECTABLE; INJECTIONVASOXYLBURROUGHS WELLCOMEMETHOXSALENLOTION; TOPICALOXSORALENPAUL B ELDERMETHOXYFLURANESOLUTION; INHALATIONPENTHRANEABBOTT LABSMETHSCOPOLAMINE BROMIDETABLET; ORALMETHSCOPOLAM:IHE BROM:IDEAA PRIVATE FORMULATIONS 2.5MGPAM:IHEAA UPJOHN 2.5MGMETHSUXIMIDECAPSULE; ORALCELONTINPARKE-DAVIS/W-LEQ lOOMG BASE/VIALlOMG/ML * 20MG/ML17099.970l50MG * 300MG
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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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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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