CDER New August 14, 2015

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

August 13, 2015


New and Generic Drug Approvals

August 12, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acetaminophen acetaminophen Suppository;Rectal Taro Pharms North Labeling Revision
Envarsus Xr tacrolimus Tablet, Extended Release;Oral Veloxis Pharma Inc Labeling Revision
Infants' Feverall acetaminophen Suppository;Rectal Taro Pharms North Labeling Revision
Levofloxacin levofloxacin Injectable; Injection Hospira Inc Approval
Sprycel dasatinib Tablet;Oral Bristol Myers Squibb Efficacy Supplement with Clinical Data to Support
Sprycel dasatinib Tablet;Oral Bristol Myers Squibb Labeling Revision

 


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