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

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APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST20CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE; INJECTIONDEXT~OSE S~ ZN ~ZNGE~'S ZN PLASTZC CONTAZNERAP ABBOTT LABS 33MG/100ML;SGM/100ML;30MG/100ML;AP860HG/100HLAP AM MCGAW/AM HOSP 33MG/100ML;SGM/100ML;30MG/100ML;AP860MG/100MLAP TRAVENOL LABS 33MG/100ML;SGM/100ML;30MG/100ML;AP860MG/100MLCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUMLACTATEINJECTABLE; INJECTIONLACTATED RINGER'S IN PLASTZC CONTAZHERAP TRAVENOL LABS 20MG/100ML;30MG/100ML;600MG/100ML;AP310MG/100MLCALCIUM GLUCEPTATECALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE;SODIUM ACETATE; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE; INJECTIONPLASMA-LYTE IN' PLASTICTRAVENOL LABSCONTAINER36.8MG/IOOML;30.5MG/IOOML;74.6MG/IOOML;640MG/IOOML;496MG/,lOOML ;89. 6MG/IOOMLCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE; INJECTIONCALCZUM GLUCEPTATEAP ABBOTT LABSAP ELI LILLYAP VITARINE/WEST CHEMCALCIUM IPODATEGRANULE; ORALORAGRAFIN CALCIUMER SQUIBB AND SONSEQ 90MG CALCZUM/SMLEQ 90MG CALCZUM/SMLEQ 90MG CALCIUM/SML3GM/PACKETINJECTABLE; INJECTION~INGE~'S IN PLASTZC CONTAINERAP ABBOTT LABS 33MG/l00ML;30MG/100ML;860MG/100MLAP TRAVENOL LABS 33MG/100ML;30MG/100ML;860MG/100MLATATSOLUTION; IRRIGATION~INGER'S IN PLASTZC CONTAZNERABBOTT LABS33MG/100ML;30MG/100ML;860MG/100ML~ZNGER'S SOLUTION IN PLASTIC CONTAIHERAM MCGAW/AM HOSP 33MG/100ML;30MG/100ML;860MG/100MLCALCIUM METRIZOATE; MAGNESIUM METRIZOATE; MEGLUMINEMETRIZOATE; SODIUM METRIZOATEINJECTABLE; INJECTIONISOPAQUE 440WINTHROP L/STERLING780 UGM/ML;15016.6MG/MLCALCIUM; MEGLUMINE; METRIZOIC ACIDUGM/MLi 75. 9MG/MLiCALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUMLACTATEINJECTABLE; INJECTIONLACTATED RINGER'S INAP ABBOTT LABSAPAP AM MCGAW/AM HOSPAPAP CUTTER LABSAPPLASTZC CONTAINER20MG/100ML;30HG/100ML;600MG/100ML;310MG/100ML20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML20MG/100ML;30MG/100ML;600MG/100ML;310MG/100MLINJECTABLE; INJECTIONISOPAQUE 280WINTHROP LISTER LINGCALUSTERONETABLET; ORALMETHOSARBUPJOHN350 UGM/MLi140.1MG/MLi461.8MG/ML50MG
APPROVED PRESCRIPTION DRUG PRODUCTSDRUG PRODUCT LIST21CANDICIDINOINTNENT; VAGINALVANOBIDMERRELL-NATIONALTABLET; VAGINALCAHOEPTrHAA SCHNID PRODUCTSVAHOBIDAA NERRELL-NATIONALCAPREONYCIN SULFATEINJECTABLE; INJECTIONCAPASTAT SULFATEELI LILLYCARBACHOL600 UGN/GN3MG3MGSOLUTION/DROPS; OPHTHALNICNIOSTATALCON LABS 0.01?CARBAMAZEPINETABLET; ORALTEGRETOLGEIGY PHARNSCARBENICILLIN DISODIUMINJECTABLE; INJECTIONGEOPEHAP ROERIG/PFIZERAPAPAPAPAPPYOPEHBEECHAN LABSEQ IGM BASE/SNL200NGEQ IGI1 BASE/VIAL JEE9 2GM BASE/VIAL JEE9 S5M BASE/VIAL * E9 10GM BASE/VIALEQ 30GN BASE/VIALE9 IG!1 BASE/VIAL JEE9 25M BASE/VIAL JEE9 SGM BASE/VIAL JEE9 10GM BASE/VIALCARBENICILLIN DISODIUNINJECTABLE; INJECTIONPYOPEHBEECHAM LABSCARBENICILLIN INDANYL SODIUMTABLET; ORALGEOCILLINROERIG/PFIZERCARBIDOPATABLET; ORALLODOSYNNERCK SHARP & DOHNECARBIDOPAj LEVODOPATABLET; ORALSINENETNERCK SHARP & DOHNECARBINOXAMINE NALEATEELIXIR; ORALCLISTINNCNEIL LABSTABLET; ORALCLISTINMCNEIL LABSCARBO PROST TROMETHAMINEINJECTABLE; INJECTIONPROSTIN/lSMUPJOHNEQ 20GM BASE/VIALEQ 382MG BASE2SMG10MG;100NG * 2SMGilOONG * 2SMG;2S0NG4NG/SNL4NGEQ 2S0 UGN BASE/NL
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
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Page 14 and 15: To assist the user in relating the
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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