March 18, 2014
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Acanya48 benzoyl peroxide; clindamycin phosphate Gel;Topical Dow Pharm Manufacturing Change or Addition
Amturnide49 aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision
Atovaquone50 atovaquone Suspension;Oral Amneal Pharms Approval
Humalog51 insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Kwikpen52 insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/5053 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/50 Kwikpen54 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 50/50 Pen55 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/2556 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 Kwikpen57 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Mix 75/25 Pen58 insulin lispro protamine recombinant; insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humalog Pen59 insulin lispro recombinant Injectable;Injection Lilly Manufacturing Change or Addition
Humulin 70/3060 insulin recombinant human; insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin 70/30 Pen61 insulin recombinant human; insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin N62 insulin susp isophane recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R63 insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Humulin R Pen64 insulin recombinant human Injectable;Injection Lilly Manufacturing Change or Addition
Janumet65 metformin hydrochloride; sitagliptin phosphate Tablet;Oral Merck Sharp Dohme Manufacturing Change or Addition
Robinul66 glycopyrrolate Injectable;Injection Hikma Maple Manufacturing Change or Addition
Tekamlo67 aliskiren hemifumarate; amlodipine besylate Tablet;Oral Novartis Labeling Revision
Tekturna68 aliskiren hemifumarate Tablet;Oral Novartis Labeling Revision
Tekturna Hct69 aliskiren hemifumarate; hydrochlorothiazide Tablet;Oral Novartis Labeling Revision