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CDER New August 4, 2015

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

August 3, 2015


New and Generic Drug Approvals

July 31, 2015

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cosopt dorzolamide hydrochloride; timolol maleate Solution/Drops;Ophthalmic Oak Pharms Inc Labeling Revision
Ddavp desmopressin acetate Solution;Nasal Ferring Pharms Inc Manufacturing Change or Addition
Ddavp desmopressin acetate Spray, Metered;Nasal Ferring Pharms Inc Manufacturing Change or Addition
Ddavp (Needs No Refrigeration) desmopressin acetate Spray, Metered;Nasal Ferring Pharms Inc Manufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.9% In Plastic Container dextrose; sodium chloride Injectable;Injection Hospira Manufacturing Change or Addition
Diovan valsartan Tablet;Oral Novartis Manufacturing Change or Addition
Fioricet W/ Codeine acetaminophen; butalbital; caffeine; codeine phosphate Capsule;Oral Actavis Labs Ut Inc Manufacturing Change or Addition
Firmagon degarelix acetate Powder;Subcutaneous Ferring Manufacturing Change or Addition
Gadavist gadobutrol Solution;Intravenous Bayer Hlthcare Labeling Revision
Hicon sodium iodide i-131 Solution;Oral Jubilant Draximage Manufacturing Change or Addition
Magnevist gadopentetate dimeglumine Injectable;Injection Bayer Hlthcare Labeling Revision
Memantine Hydrochloride memantine hydrochloride Tablet; Oral Upsher Smith Approval
Motrin Ib ibuprofen Tablet;Oral Mcneil Manufacturing Change or Addition
Motrin Migraine Pain ibuprofen Tablet;Oral Mcneil Manufacturing Change or Addition
Naphcon-A naphazoline hydrochloride; pheniramine maleate Solution/Drops;Ophthalmic Alcon Manufacturing Change or Addition
Natrecor nesiritide recombinant For Solution;Intravenous Scios Llc Manufacturing Change or Addition
Neostigmine Methylsulfate neostigmine methylsulfate Solution;Intravenous Fresenius Kabi Usa Manufacturing Change or Addition
Nuprin ibuprofen Tablet;Oral Mcneil Manufacturing Change or Addition
Ortho Tri-Cyclen Lo ethinyl estradiol; norgestimate Tablet;Oral-28 Janssen Pharms Labeling Revision
Rapamune sirolimus Solution;Oral Pf Prism Cv Manufacturing Change or Addition
Robinul glycopyrrolate Tablet;Oral Shionogi Inc Manufacturing Change or Addition
Robinul Forte glycopyrrolate Tablet;Oral Shionogi Inc Manufacturing Change or Addition
Sodium Iodide I-131 sodium iodide i-131 Capsule;Oral Jubilant Draximage Manufacturing Change or Addition
Vantas histrelin acetate Implant;Subcutaneous Endo Pharm Manufacturing Change or Addition
Yaz drospirenone; ethinyl estradiol Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition

 


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