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New and Generic Drug Approvals


August 21, 2012
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Doxycyclinedoxycycline hyclateInjectable; InjectionPfizerApproval
Duleraformoterol fumarate; mometasone furoateAerosol, Metered; InhalationMerck Sharp DohmeLabeling Revision
Mycophenolic Acidmycophenolic acidTablet, Delayed Release; OralApotex IncApproval
Veramystfluticasone furoateSpray, Metered; NasalGlaxosmithklineEfficacy Supplement with Clinical Data to Support

August 20, 2012
Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Combiventalbuterol sulfate; ipratropium bromideAerosol, Metered; InhalationBoehringer IngelheimLabeling Revision
Epi E Z Pen JrepinephrineInjectable; IntramuscularMeridian Medcl TechnLabeling Revision
EpipenepinephrineInjectable; IntramuscularMeridian Medcl TechnLabeling Revision
Epipen E Z PenepinephrineInjectable; IntramuscularMeridian Medcl TechnLabeling Revision
Epipen Jr.epinephrineInjectable; IntramuscularMeridian Medcl TechnLabeling Revision
Ziprasidone Hydrochlorideziprasidone hydrochlorideCapsule; OralWockhardt LtdTentative Approval

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