CDER New July 10, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 9, 2014


New and Generic Drug Approvals

July 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Celexa citalopram hydrobromide Tablet;Oral Forest Labs Labeling Revision
Conray iothalamate meglumine Injectable;Injection Mallinckrodt Labeling Revision
Conray 43 iothalamate meglumine Injectable;Injection Mallinckrodt Labeling Revision
Crestor rosuvastatin calcium Tablet;Oral Ipr Labeling Revision
Frovatriptan Succinate frovatriptan succinate Tablet;Oral Mylan Pharms Inc Tentative Approval
Quetiapine Fumarate quetiapine fumarate Tablet, Extended Release;Oral Mylan Pharms Inc Tentative Approval
Valchlor mechlorethamine hydrochloride Gel;Topical Actelion Pharms Ltd Manufacturing Change or Addition
Vantas histrelin acetate Implant;Subcutaneous Endo Pharm Labeling Revision

 


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