USFDA: New and Generic Drug Approvals: 02 SEP 2014

New and Generic Drug Approvals

September 2, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ibandronate Sodiumibandronate sodiumInjectable;IntravenousSagent PharmsApproval
Ibandronate Sodiumibandronate sodiumInjectable;IntravenousAgila SpecltsApproval
Ibandronate Sodiumibandronate sodiumInjectable;IntravenousEmcure Pharms LtdApproval
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateSolution;IrrigationB BraunManufacturing Change or Addition
Sodium Acetate In Plastic Containersodium acetate anhydrousInjectable;InjectionHospiraManufacturing Change or Addition

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