USFDA: New and Generic Drug Approvals: 03 NOV 2014

New and Generic Drug Approvals

November 3, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Desonide desonide Lotion;Topical Taro Approval
Furadantin nitrofurantoin Suspension;Oral Shionogi Inc Manufacturing Change or Addition
Kyprolis carfilzomib Powder;Intravenous Onyx Pharms Manufacturing Change or Addition
Lamivudine lamivudine Solution;Oral Silarx Pharms Inc Approval
Levitra vardenafil hydrochloride Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition
Lunesta eszopiclone Tablet;Oral Sunovion Pharms Inc Manufacturing Change or Addition
Marqibo Kit vincristine sulfate Injectable, Liposomal;Intravenous Talon Therap Manufacturing Change or Addition
Northera droxidopa Capsule;Oral Lundbeck Na Ltd Manufacturing Change or Addition

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