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New and Generic Drug Approvals


August 30, 2012
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Alfuzosin Hydrochloridealfuzosin hydrochlorideTablet, Extended Release; OralAurobindo PharmaApproval
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release; OralWockhardt LtdApproval
LinzesslinaclotideCapsule; OralForest Labs IncApproval
NeoralcyclosporineCapsule; OralNovartisLabeling Revision
NeoralcyclosporineSolution; OralNovartisLabeling Revision
Revatiosildenafil citrateTablet; OralPfizerEfficacy Supplement with Clinical Data to Support
Revatiosildenafil citrateSolution; IntravenousPfizerEfficacy Supplement with Clinical Data to Support
RevatiosildenafilSuspension; OralPfizer IncApproval
SandimmunecyclosporineInjectable; InjectionNovartisLabeling Revision
SandimmunecyclosporineSolution; OralNovartisLabeling Revision
SandimmunecyclosporineCapsule; OralNovartisLabeling Revision
SubsysfentanylSpray; SublingualInsys TherapLabeling Revision

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