What's New on the FDA Drugs Site
April 4, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 3, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acyclovir | acyclovir | Ointment; Topical | Mylan Pharms Inc | Approval |
| Aldurazyme | laronidase | Vial | Biomarin | Labeling Revision |
| Ampicillin Sodium | ampicillin sodium | Injectable; Injection | Acs Dobfar Spa | Approval |
| Ampicillin Sodium | ampicillin sodium | Injectable; Injection | Acs Dobfar Spa | Approval |
| Coartem | artemether; lumefantrine | Tablet; Oral | Novartis | Manufacturing Change or Addition |
| Eligard | leuprolide acetate | Injectable; Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Enablex | darifenacin hydrobromide | Tablet, Extended Release; Oral | Warner Chilcott Llc | Manufacturing Change or Addition |
| Eszopiclone | eszopiclone | Tablet; Oral | Sun Pharma Global | Approval |
| Metastron | strontium chloride sr-89 | Injectable; Injection | Ge Healthcare | Manufacturing Change or Addition |
| Xarelto | rivaroxaban | Tablet; Oral | Janssen Pharms | Manufacturing Change or Addition |
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