Mar 042016
 

March 4, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Adcetris brentuximab vedotin Injectable; Injection Seattle Genetics Labeling Revision
H.P. Acthar Gel corticotropin Injectable;Injection Mallinckrodt Ard Manufacturing Change or Addition
Imbruvica ibrutinib Capsule;Oral Pharmacyclics Inc Supplement
Lamivudine lamivudine Tablet;Oral Mylan Pharms Inc Approval
Lasix furosemide Tablet;Oral Us Pharm Holdings Labeling Revision
Maxipime cefepime hydrochloride Injectable;Injection Hospira Inc Manufacturing Change or Addition
Potassium Chloride potassium chloride Capsule, Extended Release;Oral Tris Pharma Inc Approval
Sodium Bicarbonate sodium bicarbonate Injectable;Injection Hospira Inc Approval
Varithena polidocanol Solution;Intravenous Provensis Manufacturing Change or Addition
Yaz drospirenone; ethinyl estradiol Tablet;Oral Bayer Hlthcare Manufacturing Change or Addition