New and Generic Drug Approvals

June 12, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acetic Acid 0.25% In Plastic Container	acetic acid, glacial	Solution;Irrigation, Urethral	Hospira	Manufacturing Change or Addition
Bacteriostatic Sodium Chloride 0.9% In Plastic Container	sodium chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Bacteriostatic Water For Injection In Plastic Container	sterile water for injection	Liquid;N/A	Hospira	Manufacturing Change or Addition
Caverject	alprostadil	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
Cerebyx	fosphenytoin sodium	Injectable;Injection	Parke Davis	Labeling Revision
Chromic Chloride In Plastic Container	chromic chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Cupric Chloride In Plastic Container	cupric chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Dovonex	calcipotriene	Cream;Topical	Leo Pharma As	Manufacturing Change or Addition
Ella	ulipristal acetate	Tablet;Oral	Lab Hra Pharma	Labeling Revision
Heparin Sodium	heparin sodium	Injectable;Injection	Shenzhen Techdow Pharma	Approval
Heparin Sodium	heparin sodium	Injectable;Injection	Shenzhen Techdow Pharma	Approval
Heparin Sodium	heparin sodium	Injectable;Injection	Shenzhen Techdow Pharma	Approval
Heparin Sodium	heparin sodium	Injectable;Injection	Shenzhen Techdow Pharma	Approval
Lamotrigine	lamotrigine	Tablet, Chewable;Oral	Alembic Pharms Ltd	Approval
Manganese Chloride In Plastic Container	manganese chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Physiosol In Plastic Container	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	Solution;Irrigation	Hospira	Manufacturing Change or Addition
Potassium Acetate In Plastic Container	potassium acetate	Injectable;Injection	Hospira	Manufacturing Change or Addition
Ringer's In Plastic Container	calcium chloride; potassium chloride; sodium chloride	Solution;Irrigation	Hospira	Manufacturing Change or Addition
Sodium Acetate In Plastic Container	sodium acetate anhydrous	Injectable;Injection	Hospira	Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container	sodium chloride	Solution;Irrigation	Hospira	Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container	sodium chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Sodium Chloride In Plastic Container	sodium chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Sodium Lactate In Plastic Container	sodium lactate	Injectable;Injection	Hospira	Manufacturing Change or Addition
Sodium Phosphates In Plastic Container	sodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrous	Injectable;Injection	Hospira	Manufacturing Change or Addition
Sterile Water For Injection In Plastic Container	sterile water for injection	Liquid;N/A	Hospira	Manufacturing Change or Addition
Taclonex	betamethasone dipropionate; calcipotriene hydrate	Ointment;Topical	Leo Pharma As	Manufacturing Change or Addition
Timentin	clavulanate potassium; ticarcillin disodium	Injectable;Injection	Glaxosmithkline	Labeling Revision
Timentin In Plastic Container	clavulanate potassium; ticarcillin disodium	Injectable;Injection	Glaxosmithkline	Labeling Revision
Tpn Electrolytes In Plastic Container	calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition
Zebeta	bisoprolol fumarate	Tablet;Oral	Teva Womens	Manufacturing Change or Addition
Ziac	bisoprolol fumarate; hydrochlorothiazide	Tablet;Oral	Teva Womens	Manufacturing Change or Addition
Zinc Chloride In Plastic Container	zinc chloride	Injectable;Injection	Hospira	Manufacturing Change or Addition