What's New on the FDA Drugs Site
April 19, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Medication Guides (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 18, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Aleve | naproxen sodium | Tablet; Oral | Bayer | Labeling Revision |
| Amlodipine; Valsartan; Hydrochlorothiazide | amlodipine; valsartan; hydrochlorothiazide | Tablet; Oral | Par Pharm Inc | Tentative Approval |
| Delflex W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution; Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Xylocaine Preservative Free | lidocaine hydrochloride | Injectable; Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
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