USFDA: New and Generic Drug Approvals: 03 SEP 2014

New and Generic Drug Approvals

September 3, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Arthrotecdiclofenac sodium; misoprostolTablet, Delayed Release;OralGd Searle LlcLabeling Revision
Dextrose 25%dextroseInjectable;InjectionHospiraManufacturing Change or Addition
Dextrose 50% In Plastic ContainerdextroseInjectable;InjectionHospiraManufacturing Change or Addition
DigoxindigoxinTablet;OralMylan Pharms IncManufacturing Change or Addition
Dorzolamide Hydrochloride and Timolol Maleatedorzolamide hydrochloride;timolol maleateSolution;OphthalmicWatson Labs IncApproval
GatifloxacingatifloxacinSolution;OphthalmicHi-Tech PharmacalApproval
Milrinone Lactatemilrinone lactateInjectable;InjectionHospira IncApproval

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