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

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APPROVED PRESCRIPTION DRUG PRODUCtSDRUG PRODUCT LIST6AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASICjSODIUM CHLORIDEINJECTABLE; INJECTIONAMINOSYN 8.S% WI ELECTROLYTESABBOTT LABS8.5X;102MG/IOOML;S22MG/IOOML;410MG/IOOMLAMINOACETIC ACIDSOLUTION; IRRIGATIONAM:IHOACET:IC AC:ID 1.57. :IN PLAST:IC CONTA:INERAT AM MCGAW/AM HOSP 1.SGM/100MLAT TRAVENOL LABS 1.SGM/100ML-- GLYC:IHE 1.57. :IH PLAST:IC COHtA:IHERAT ABBOTT LABS 1.SGM/100MLAMINOCAPROIC ACIDINJECTABLE; INJECTIONAMI CARLEDERLE PARENTERALS250MG/MLSYRUP; ORALAMICARLEDERLE LABS/AM CYAN 250MG/MLTABLET; ORALAMI CARLEDERLE LABS/AN CYAN 500MGAMINOHIPPURATE SODIUMINJECTABLE; INJECTIONAMINOHIPPURATE SODIUMMERCK SHARP & DOHME 207.AMINOPHYlLINEINJECTABLE; INJECTIONAM:IHOPHYLL:IHEAP BEECHAM LABS ZSMG/MLAMINOPHYLLINEINJECTABLE; INJECTIONAMJ:HOPHYLLJ:HEAP VITARINE/WEST CHEN ZSMG/MLLIQUID; ORALSOMOPHYLLINFISONSTABLET; ORALAMINOPHYLLINBD SEARLE PH ARMSAMINOPHYLLINEBD CHELSEA LABSCORD LABSBD HALSEY DRUGBD HEUN-NORWOOD LABSBD ICN PHARMSBD LANNETTBD PANRAY/ORMONT DRUGBD PHOENIX LABSBD RICHLYN LABSBD STAN LABS PHARMBD VALE CHEMICALBD WEST-WARDIOSMG/5MLIOOMG * 200MGTABLET, CONTROLLED RELEASE; ORALPHYlLOCONTINPURDUE FREDERICK 225MGTABLET. ENTERIC COATED; ORALAMINOPHYlLINEBD RICHLYN LABSBD TABLICAPSBD VALE CHEMICALAMINOSALICYLIC ACIDTABLET; ORALPARASALPANRAY/ORMONT DRUGTABLET. ENTERIC COATED; ORALAMINOSALICYLIC ACIDELI LILLY500MGIOOMG * 200MG97.2MG * 194.4MGlOOMGIOONG * 200MG200MG.IOOMG * 200MGIOOMG * 200MGlOOMG * 200MGIOOMG * 200MGlOOMG * 200MGIOOMGIOOMG * 200MGIOOMG * 200MGIOOMGlOOMG * 200MG500MG * IGM
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST7AMINOSALICYLIC ACID RESIN COMPLEXPOWDER; ORALREZIPASER SQUIBB AND SONSAMINOSALICYLIC ACID; ISONIAZID500MG/GMTABLET; ORALBUFFERED PARASAL-INH 20PANRAY/ORMONT DRUG 500MG;20MGAMINOSALICYLIC ACID; SODIUM AMINOSALICYLATETABLET; ORALNEOPASALATEWALLACE LABS/C-WAMITRIPTYLINE HYDROCHLORIDECONCENTRATE; ORALENDEP'HOFFMANN-LA ROCHE112MG;846MG40MG/l1LINJECTABLE; INJECTIONAMITRIPTYLINE HClAP CARTER-GL03AU LABS 10MG/MlElAVIlAP MERCK SHARP & DOHME 10MG/MlTABLET; ORALAMITIDBP ER SQUIBB AND SONSAMITRIlBP PARKE-DAVIS/W-LBPAMITRIPTYLINE HClAB BARR LABSAB BIOCRAFT LABSAB CHELSEA LABSABAB CORD LABSAB10MG * 25MG * 50MG * 75MG * 100MG10MG * 25MG * 50MG * 75MG * 100MG *150MG10MG * 2SMG * SOMG * 7SMG * 100MG10MG * 2SMG * SOMG * 7SMG * 100MG10MG * 2SMG * SOMG * 7SMG * 100MG *lSOMG10MG * 2SMG * SOMG * 7SMG * lOOMG *lSOMGAMITRIPTYLINE HYDROCHLORIDETABLET; ORALAMITRIPTYLINE HClBP HALSEY DRUG 10MG * 25MGBP IKAPHARM LTD 10MG * 25MG * 50MG * 75MG * 100MG *BPAB150MGLEDERLE LABS/AM CYAN 10MG * 2SMG * SOMG * 7SMG * 100MGAB MD PHARM !Qtl2* 2SMG * SOMG * 7SMG * 100MG *ABlSOMGAB MYLAN PHARMS 10MG * 2SMG * SOMG * 7SMG * 100MG *ASlSOHGAB PHILIPS ROXANE LABS 10MG * 2SMG * SOMG * 7SMG * 100MG *ABlSOMGABASABASElAV:rLMERCK SHARP & DOHMEEHDEPHOFFMANN-LA ROCHE10MG * 2SMG * SOMG * 7SMG * 100MG *llQ.!:!§10MG * 2SMG * SOMG * 7SMG * 100MG *lSOMGSK-AM:rTRIPTYlIHEAB PHILIPS ROXANE LABS lOMG * 2SMG M SOMG * 7SMG * 100MG *ASlSOMGAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDETABLET; ORALLIMBITROLHOFFMANN-LA ROCHE12.5MG;5MG * 25MGilOMGAMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINETABLET; ORALETRAFON ABP SCHERING lOMGi4MGETRAFON 2-10BP SCHERING lOMGi2MGETRAFON 2-25BP SCHERING 25MGi2MGETRAFON-FORTEBP SCHERING 25MG;4MGTRIAVIL 2-10BP MERCK SHARP & DOHME lOMGi2MGTRIAVIl 2-25BP MERCK SHARP & DOHME 25MG;2MG
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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