CDER New December 18, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

December 17, 2014


New and Generic Drug Approvals

December 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Chg Scrub chlorhexidine gluconate Solution;Topical Ecolab Manufacturing Change or Addition
Cida-Stat chlorhexidine gluconate Solution;Topical Ecolab Manufacturing Change or Addition
Diastat diazepam Gel;Rectal Valeant Pharms North Labeling Revision
Diastat Acudial diazepam Gel;Rectal Valeant Pharms North Labeling Revision
Diclegis doxylamine succinate; pyridoxine hydrochloride Tablet, Delayed Release;Oral Duchesnay Labeling Revision
Primaxin cilastatin sodium; imipenem Powder;Intravenous Merck Labeling Revision
Somatuline Depot lanreotide acetate Injectable;Subcutaneous Ipsen Pharma Supplement
Wellbutrin bupropion hydrochloride Tablet;Oral Glaxosmithkline Labeling Revision
Wellbutrin Sr bupropion hydrochloride Tablet, Extended Release;Oral Glaxosmithkline Labeling Revision

 


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