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CDER New August 23, 2012

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

August 22, 2012

August 21, 2012

August 20, 2012


New and Generic Drug Approvals

August 21, 2012

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Doxycycline doxycycline hyclate Injectable; Injection Pfizer Approval
Dulera formoterol fumarate; mometasone furoate Aerosol, Metered; Inhalation Merck Sharp Dohme Labeling Revision
Mycophenolic Acid mycophenolic acid Tablet, Delayed Release; Oral Apotex Inc Approval
Veramyst fluticasone furoate Spray, Metered; Nasal Glaxosmithkline Efficacy Supplement with Clinical Data to Support

 

August 20, 2012

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Combivent albuterol sulfate; ipratropium bromide Aerosol, Metered; Inhalation Boehringer Ingelheim Labeling Revision
Epi E Z Pen Jr epinephrine Injectable; Intramuscular Meridian Medcl Techn Labeling Revision
Epipen epinephrine Injectable; Intramuscular Meridian Medcl Techn Labeling Revision
Epipen E Z Pen epinephrine Injectable; Intramuscular Meridian Medcl Techn Labeling Revision
Epipen Jr. epinephrine Injectable; Intramuscular Meridian Medcl Techn Labeling Revision
Ziprasidone Hydrochloride ziprasidone hydrochloride Capsule; Oral Wockhardt Ltd Tentative Approval

 


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