April 15, 2014
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Eligard42 leuprolide acetate Injectable;Subcutaneous Tolmar Therap Manufacturing Change or Addition
Eszopiclone43 eszopiclone Tablet;Oral Dr Reddys Labs Ltd Approval
Eszopiclone44 eszopiclone Tablet;Oral Roxane Approval
Eszopiclone45 eszopiclone Tablet;Oral Glenmark Generics Approval
Excedrin (Migraine)46 acetaminophen; aspirin; caffeine Tablet;Oral Novartis Labeling Revision
Neurontin47 gabapentin Solution;Oral Parke Davis Manufacturing Change or Addition
Ramipril48 ramipril Capsule;Oral Accord Hlthcare Inc Approval
Sitagliptin Phosphate49 sitagliptin phosphate Tablet;Oral Watson Labs Inc Tentative Approval
Tanzeum50 albiglutide Injectable;Injection Glaxosmithkline Llc Approval