What's New on the FDA Drugs Site
May 22, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- National Drug Code Directory
- Presentation: Coming of Age of Personalized Medicine (PDF - 797KB)
- Preventing Surgical Fires: Initiative Partners (updated)
New and Generic Drug Approvals
May 21, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cuvposa | glycopyrrolate | Solution; Oral | Merz Pharms | Labeling Revision |
| Dopamine Hydrochloride In Dextrose 5% In Plastic Container | dopamine hydrochloride | Injectable; Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Lanoxin | digoxin | Tablet; Oral | Covis Pharma | Manufacturing Change or Addition |
| Methergine | methylergonovine maleate | Injectable; Injection | Us Pharms Holdings I | Manufacturing Change or Addition |
| Methergine | methylergonovine maleate | Tablet; Oral | Us Pharms Holdings I | Manufacturing Change or Addition |
| Optimark | gadoversetamide | Injectable; Injection | Mallinckrodt | Labeling Revision |
| Optimark | gadoversetamide | Injectable; Injection | Mallinckrodt | Labeling Revision |
| Optimark In Plastic Container | gadoversetamide | Injectable; Injection | Mallinckrodt | Labeling Revision |
| Razadyne | galantamine hydrobromide | Tablet; Oral | Janssen Pharms | Manufacturing Change or Addition |
| Razadyne | galantamine hydrobromide | Solution; Oral | Janssen Pharms | Manufacturing Change or Addition |
| Razadyne Er | galantamine hydrobromide | Capsule, Extended Release; Oral | Janssen Pharms | Manufacturing Change or Addition |
| Stelara | ustekinumab | Injectable; Injection | Centocor Ortho Biotech Inc | Efficacy Supplement with Clinical Data to Support |
| Sumatriptan Succinate | sumatriptan succinate | Tablet; Oral | Hikma Pharms | Approval |
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