What's New on the FDA Drugs Site
February 12, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
- Manual of Policies and Procedures (MAPP) 5230.3 (PDF - 83KB) Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act
New and Generic Drug Approvals
February 11, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Janumet Xr | metformin hydrochloride; sitagliptin phosphate | Tablet, Extended Release; Oral | Merck Sharp Dohme | Labeling Revision |
| Juvisync | simvastatin; sitagliptin phosphate | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
