CDER New July 7, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 3, 2014


New and Generic Drug Approvals

July 2, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Azor amlodipine besylate; olmesartan medoxomil Tablet;Oral Daiichi Sankyo Labeling Revision
Bendamustine Hydrochloride Injection bendamustine hydrochloride Injectable; Injection Eagle Pharms Tentative Approval
Letairis ambrisentan Tablet;Oral Gilead Manufacturing Change or Addition
Norpramin desipramine hydrochloride Tablet;Oral Sanofi Aventis Us Labeling Revision
Qualaquin quinine sulfate Capsule;Oral Mutual Pharm Co Inc Labeling Revision

 


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