USFDA: New and Generic Drug Approvals: 30 MAR 2015

New and Generic Drug Approvals

March 30, 2015

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aceon perindopril erbumine Tablet;Oral Symplmed Pharms Llc Labeling Revision
Advil Congestion Relief ibuprofen; phenylephrine hydrochloride Tablet;Oral Pfizer Labeling Revision
Cesamet nabilone Capsule;Oral Meda Pharms Manufacturing Change or Addition
Choline C-11 choline c-11 Injectable;Intravenous Mcprf Manufacturing Change or Addition
Depakote Er divalproex sodium Tablet, Extended Release;Oral Abbvie Labeling Revision
Edecrin ethacrynic acid Tablet;Oral Aton Manufacturing Change or Addition
Estrostep 21 ethinyl estradiol; norethindrone acetate Tablet;Oral-21 Warner Chilcott Llc Manufacturing Change or Addition
Estrostep Fe ethinyl estradiol; norethindrone acetate Tablet;Oral-28 Warner Chilcott Llc Manufacturing Change or Addition
Fanapt iloperidone Tablet;Oral Vanda Pharms Inc Manufacturing Change or Addition
Omeprazole omeprazole Tablet, Delayed Release;Oral Dexcel Pharma Manufacturing Change or Addition
Pancreaze pancrelipase (amylase;lipase;protease) Capsule, Delayed Release;Oral Janssen Pharms Manufacturing Change or Addition
Qudexy Xr topiramate Capsule, Extended Release;Oral Upsher Smith Efficacy Supplement with Clinical Data to Support
Rapamune sirolimus Tablet;Oral Pf Prism Cv Manufacturing Change or Addition
Retisert fluocinolone acetonide Implant;Intravitreal Bausch and Lomb Manufacturing Change or Addition
Salonpas menthol; methyl salicylate Patch;Topical Hisamitsu Pharm Co Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Solution;Irrigation B Braun Manufacturing Change or Addition
Solaraze diclofenac sodium Gel;Topical Fougera Pharms Manufacturing Change or Addition
Sterile Water In Plastic Container sterile water for irrigation Liquid;Irrigation B Braun Manufacturing Change or Addition
Topotecan Hydrochloride topotecan hydrochloride Solution;Intravenous Teva Pharms Usa Manufacturing Change or Addition
Urex methenamine hippurate Tablet;Oral Cnty Line Pharms Manufacturing Change or Addition
Zaroxolyn metolazone Tablet;Oral Ucb Inc Manufacturing Change or Addition

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