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New and Generic Drug Approvals


June 19, 2012
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Helidacbismuth subsalicylate; metronidazole; tetracycline hydrochlorideTablet, Chewable, Tablet, Capsule; OralPrometheus LabsLabeling Revision
Helidacbismuth subsalicylate; metronidazole; tetracycline hydrochlorideTablet, Chewable, Tablet, Capsule; OralPrometheus LabsManufacturing Change or Addition
Olanzapine; Fluoxetine Hydrochlorideolanzapine; fluoxetine hydrochlorideCapsule; OralTeva PharmsApproval
Sumatriptan Succinatesumatriptan succinateTablet; OralApotex IncApproval

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