USFDA: New and Generic Drug Approvals: 16 NOV 2014

New and Generic Drug Approvals

November 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Choline C-11choline c-11Injectable;IntravenousMcprfManufacturing Change or Addition
Fiorinal W/Codeineaspirin; butalbital; caffeine; codeine phosphateCapsule;OralWatson Labs IncManufacturing Change or Addition
Injectaferferric carboxymaltoseInjectable;IntravenousLuitpoldManufacturing Change or Addition
Morphine Sulfatemorphine sulfateSolution;Intramuscular, IntravenousBd RxManufacturing Change or Addition
Resectisol In Plastic ContainermannitolSolution;IrrigationB BraunManufacturing Change or Addition
Zytigaabiraterone acetateTablet;OralJanssen BiotechManufacturing Change or Addition

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