CDER New December 29, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

December 24, 2014

December 23, 2014


New and Generic Drug Approvals

December 22, 2014

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Cordarone amiodarone hydrochloride Tablet;Oral Wyeth Pharms Inc Labeling Revision
Dextrose 10% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 20% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 30% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 40% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.075% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.15% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.224% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% and Potassium Chloride 0.3% In Plastic Container dextrose; potassium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 5% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 50% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 50% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 60% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 60% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 70% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Dextrose 70% In Plastic Container dextrose Injectable;Injection Baxter Hlthcare Labeling Revision
Extavia interferon beta-1b Injectable; Subcutaneous Novartis Pharms Labeling Revision
Opdivo nivolumab Injectable;Injection Bristol Myers Squibb Approval
Plasma-Lyte 56 and Dextrose 5% In Plastic Container dextrose; magnesium acetate tetrahydrate; potassium acetate; sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Potassium Chloride potassium chloride Solution; Oral Pharma-Med Inc Approval
Remodulin treprostinil Injectable;Iv (Infusion), Subcutaneous United Therap Labeling Revision
Sodium Chloride 0.45% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Sodium Chloride 3% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Sodium Chloride 5% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Labeling Revision
Somatuline Depot lanreotide acetate Injectable;Subcutaneous Ipsen Pharma Labeling Revision
Tykerb lapatinib ditosylate Tablet;Oral Smithkline Beecham Labeling Revision

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