Feb 232016
 

February 23, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Complera emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Efficacy Supplement with Clinical Data to Support
Complera emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Dextrose 5% In Plastic Container dextrose Injectable;Injection Hospira Manufacturing Change or Addition
Diclofenac Potassium diclofenac potassium Capsule;Oral Bionpharma Inc Approval
Levetiracetam levetiracetam Tablet, Extended Release;Oral Intellipharmaceutics Approval
Lurasidone Hydrochloride lurasidone hydrochloride Tablet;Oral Emcure Pharms Ltd Tentative Approval
Norgestimate and Ethinyl Estradiol ethinyl estradiol; norgestimate Tablet;Oral-28 Glenmark Pharms Ltd Approval
Sodium Polystyrene Sulfonate sodium polystyrene sulfonate Powder;Oral, Rectal Belcher Pharms Llc Approval
Xeljanz tofacitinib Tablet, Extended Release;Oral Pfizer Inc Approval