CDER New March 20, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

March 19, 2014


New and Generic Drug Approvals

March 18, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acanya benzoyl peroxide; clindamycin phosphate Gel;Topical Dow Pharm Manufacturing Change or Addition
Amturnide aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision
Atovaquone atovaquone Suspension;Oral Amneal Pharms Approval
Humalog insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Kwikpen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/50 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/50 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/50 Pen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 Kwikpen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 Pen insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Pen insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humulin 70/30 insulin recombinant human; insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin 70/30 Pen insulin recombinant human; insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin N insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R Pen insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Janumet metformin hydrochloride; sitagliptin phosphate Tablet;Oral Merck Sharp Dohme Manufacturing Change or Addition
Robinul glycopyrrolate Injectable;Injection Hikma Maple Manufacturing Change or Addition
Tekamlo aliskiren hemifumarate; amlodipine besylate Tablet;Oral Novartis Labeling Revision
Tekturna aliskiren hemifumarate Tablet;Oral Novartis Labeling Revision
Tekturna Hct aliskiren hemifumarate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision

 


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