What's New on the FDA Drugs Site
August 28, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA's Clinical Investigator Training Course, November 12-14, 2013, The Holiday Inn, College Park, MD 20740. Meeting information and registration
- National Drug Code Directory
New and Generic Drug Approvals
August 28, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride | dexmethylphenidate hydrochloride | Capsule, Extended Release; Oral | Mylan Pharms Inc | Approval |
August 27, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Anthelios Sx | avobenzone; ecamsule; octocrylene | Cream; Topical | Loreal Usa | Manufacturing Change or Addition |
| Heparin Sodium | heparin sodium | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Omniscan | gadodiamide | Injectable; Injection | Ge Healthcare | Labeling Revision |
| Omniscan | gadodiamide | Injectable; Injection | Ge Healthcare | Labeling Revision |
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