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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST4ALBUMIN. IODINATED, I-12S, SERUMINJECTABLE; INJECTIONRADIO-IODINATED (I 12S) SERUM ALBUMIN (HUMAN)AMES DIV MILES LABS 2.S UCI/AMPRADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 12SMALLINCKRODT 6.7-100 UCI/MLALBUMIN, IODINATED, 1-131, SERUMINJECTABLE; INJECTIONALBUMOTOPE 131 IER SQUIBB AND SONS S UCI/AMP * 20 UCI/AMP *SOO UCI/VIAL * IMCI/VIAL * 2MCI/VIALRADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 131MALLINCKRODT 6.7-2S0 UCI/MLALCOHOLj DEXTROSEINJECTABLE; INJECTIONALCOHOL 10% AND DEXTROSE 5% IN DISTILLED WATERAM MCGAW/AM HOSP 10ML/I00MLjSGM/I00MLALCOHOL 57. AHD DEXTROSE 57. IH DISTILLED WATERAP AM MCGAW/AM HOSP 5ML/100ML;5GM/100ML-- ALCOHOL 57. IH DEXTROSE 5~AP CUTTER LABS 5ML/100ML;5GM/100ML-- ALCOHOL 5~ IH DEXTROSE 5~ IH WATERAP TRAVENOL LABS 5ML/100ML;5GM/100ML-- ALCOHOL 5~ IH D5-WAP ABBOTT LABS SML/100ML;5GM/100MLALKAVERVIRTABLET; ORALVERILOIDRIKER LABS/3M2MG * 3MGALKYL AMMONIUM SULFONIC ACID BETAINE (SULFOBETAINE DEH)jAMMONIUM SALT OF C-12-C-lS LINEAR PRIMARY ALCOHOL ETHOXYLATEjEDETATE SODIUMj ETHOMEEN C-2S; HEXACHLOROPHENE; LANOLINALCOHOLS, ACETYLATEDSPONGE; TOPICALE-Z SCRUB SURGICALPARKE-DAVIS/W-L7.89Y.;17.73Y.;O.14Y.;3Y.;4S0MG;0.24Y.ALLOPURINOLTABLET; ORALALLOPURIHOLAS GENERIC PHARM/IVY lOOMS • ~ZYLOPRIHAS BURROUGHS WELLCOME ~. 300MBALSEROXYlONTABLET; ORALRAUTENSINBP,DORSEY LABS/SANDOZRAUWILOID2MGBP RIKER LABS/3M 2MGALUMINUM ACETATE; *MULTIPLE*SEE ACETIC ACID, GLACIAL; ALUMINUM ACETATEALUMINUM CHLORHYDROXY ALLANTIONATEj PREDNISOLONECREAM; tOPICALMETI-DERMSCHERINGALUMINUM NICOTINATETABLET; ORALNICALEXMERRELL-NATIONALAMANTADINE HYDROCHLORIDECAPSULE; ORALSYMMETRELENDO LABS/DUPONTSYRUP; ORALSYMMETRElENDO LABS/DUPONT2.SMG/GM;O.SY.62SMG100MGSOMG/SML
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST5AMBENONIVM,CHLORIDETABLET; ORALMYTELASEWINTHROP L/STERLINGAMCINONIDE10MGCREAM; TOPICALCYCLOCORTLEDERLE LABS/AM CYAN 0.0257. * 0.17-AMIKACIN SULFATEINJECTABLE; INJECTIONAMIKINBRISTOL LABS/BMAMINO ACIDSINJECTABLE; INJECTIONAMlHOSYN 107-ABBOTT LABS 107-AMlNOSYN 57-ABBOTT LABS 57-AMlNOSYN 77.ABBOTT LABS 77-AMlNOSYN 8.57-AaBOTT LABS 8.57-FREAtfINE II 8.57-AM MCGAW/AM HOSP 8.57-FREAMINE III 8.57.AH MCGAW/AM HOSP 8.57-FREAMINE 8.57-AM MCGAW/AM HOSP 8.57-NEP~AMINE 5.47-AM MCGAW/At! HOSP 5.47-TRAVASOL 107- W/O ELECTROLYTESTRAVENOL LABS 107-TRAVASOL 5.57- WIO ELECTROLYTEST~AVENOL LABS 5.57-TRAVASOL 8.57- WIO ELECTROLYTESTRAVENOL LABS 8.57-EQ 50MG BASE/ML * EQ 250MG BASE/MLAMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUMCHLORIDE; SODIUM ACETATE; SODIUM CHLORIDEINJECTABLE; INJECTIONFREAMINE III 37- W/ ELECTROLYTESAM MCGAW/AM HOSP 37-;54MGj41MGj149MG;204MGjl17MGAMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUMCHLORIDEINJECTABLE; INJECTIONAMINOSYNABBOTT LABS3.57-;21MG/IOOMLj128MG/IOOMLj234MG/IOOMLAMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMACETATE; POTASSIUM CHLORIDE; SODIUM ACETATEINJECTABLE; INJECTIONVEINAMINE 87-CUTTER LABS87-j61MG/IOOMLj211MG/IOOMLj56MG/IOOML;388MG/IOOMLAMINO ACIDS; MAGNESIUM CHLORIDE HEXAHYDRATE; POTASSIUMPHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDEINJECTABLE; INJECTIONTRAVASOL M 3.57- W/ ELECTROLYTE 45TRAVENOL LABS 3.5/.j51MG/IOOMLj131MG/IOOMLj218MG/IOOML;35MG/IOOMLTRAVASOL 5.57- W/ ELECTROLYTESTRAVENOL LABS 5.5/.;102MG/IOOMLj522MG/IOOML;431MG/IOOML;224MG/IOOMLTRAVASOL 8.5/. W/ ELECTROLYTESTRAVENOL LABS 8.S/.;102MG/IOOML;522MG/IOOML;594MG/IOOMLj154MG/IOOMLAMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE. DIBASIC;SODIUM CHLORIDEINJECTABLE; INJECTIONAMINOSYN 77- WI ELECTROLYTESABBOTT LABS7/.jl02MG/100ML;522MG/100ML;410MG/IOOML
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
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