USFDA: New and Generic Drug Approvals: 25 AUG 2014

New and Generic Drug Approvals


August 25, 2014
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BacitracinbacitracinInjectable;InjectionXellia Pharms ApsApproval
Buspirone Hydrochloridebuspirone hydrochlorideTablet;OralStrides Arcolab LtdApproval
DiabetaglyburideTablet;OralSanofi Aventis UsManufacturing Change or Addition
FaslodexfulvestrantInjectable;IntramuscularAstrazenecaManufacturing Change or Addition
Invega Sustennapaliperidone palmitateSuspension, Extended Release;IntramuscularJanssen PharmsManufacturing Change or Addition
Kabiven and Perikabivenamino acids;electrolytes;dextrose;lipidInjectable;InjectionFresenius KabiApproval
Membranebluetrypan blueSolution;OphthalmicDorcManufacturing Change or Addition
Oxacillin Sodiumoxacillin sodiumInjectable;InjectionAgila SpecltsApproval
Tafinlardabrafenib mesylateCapsule;OralGlaxosmithklineManufacturing Change or Addition
TricorfenofibrateTablet;OralAbbvieManufacturing Change or Addition
Visionbluetrypan blueSolution;OphthalmicDorcManufacturing Change or Addition

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