Thursday, 18 July 2013

CDER New July 18, 2013

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 17, 2013


New and Generic Drug Approvals

July 16, 2013

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acamprosate Calcium acamprosate calcium Tablet, Delayed Release; Oral Glenmark Generics Approval
Eliquis apixaban Tablet; Oral Bristol Myers Squibb Manufacturing Change or Addition
Eloxatin oxaliplatin Injectable; Iv (Infusion) Sanofi Aventis Us Labeling Revision
Elspar asparaginase Vial Merck Labeling Revision

 


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