Feb 252016
 

February 25, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Aleve naproxen sodium Tablet;Oral Bayer Manufacturing Change or Addition
Elelyso taliglucerase alfa Powder;Iv (Infusion) Pfizer Manufacturing Change or Addition
Elestat epinastine hydrochloride Solution/Drops;Ophthalmic Allergan Manufacturing Change or Addition
Premphase 14/14 estrogens, conjugated; medroxyprogesterone acetate Tablet;Oral-28 Wyeth Pharms Inc Manufacturing Change or Addition
Prempro estrogens, conjugated; medroxyprogesterone acetate Tablet;Oral-28 Wyeth Pharms Inc Manufacturing Change or Addition
Ritonavir ritonavir Tablet;Oral Aurobindo Pharma Ltd Tentative Approval
Solu-Cortef hydrocortisone sodium succinate Injectable;Injection Pharmacia and Upjohn Manufacturing Change or Addition
Stalevo 100 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 125 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 150 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 200 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 50 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Stalevo 75 carbidopa; entacapone; levodopa Tablet;Oral Orion Pharma Manufacturing Change or Addition
Survanta beractant Suspension;Intratracheal Abbvie Manufacturing Change or Addition
Truvada emtricitabine; tenofovir disoproxil fumarate Tablet;Oral Gilead Labeling Revision