USFDA: New and Generic Drug Approvals: 25 NOV 2014

New and Generic Drug Approvals

November 25, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AmoxilamoxicillinFor Suspension;OralDr Reddys Labs IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralSandozLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet;OralApotex IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralSun Pharma GlobalLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralActavis Labs Fl IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralMylanLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralAnchen PharmsLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralZydus Pharms Usa IncLabeling Revision
Bupropion Hydrochloridebupropion hydrochlorideTablet, Extended Release;OralJubilant GenericsLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Extended Release;OralReddysLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Delayed Release;OralAurobindo Pharma LtdLabeling Revision
Divalproex Sodiumdivalproex sodiumTablet, Extended Release;OralAurobindo Pharma LtdLabeling Revision
LarotidamoxicillinFor Suspension;OralDr Reddys Labs IncLabeling Revision
LucentisranibizumabInjectable; InjectionGenentechEfficacy Supplement with Clinical Data to Support
Norcoacetaminophen; hydrocodone bitartrateTablet;OralWatson LabsLabeling Revision
PriftinrifapentineTablet;OralSanofi Aventis UsEfficacy Supplement with Clinical Data to Support
TopiramatetopiramateCapsule;OralZydus Pharms Usa IncLabeling Revision
Tussicapschlorpheniramine polistirex; hydrocodone polistirexCapsule, Extended Release;OralEcr PharmaLabeling Revision

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