What's New on the FDA Drugs Site
August 2, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- MedWatch Safety Alert: Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter
- National Drug Code Directory
New and Generic Drug Approvals
August 1, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Altabax | retapamulin | Ointment; Topical | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Amaryl | glimepiride | Tablet; Oral | Sanofi Aventis Us | Labeling Revision |
| Desogestrel; Ethinyl Estradiol; Ethinyl Estradiol | desogestrel; ethinyl estradiol; ethinyl estradiol | Tablet; Oral | Novast Labs Ltd | Approval |
| Ditropan Xl | oxybutynin chloride | Tablet, Extended Release; Oral | Janssen Pharms | Labeling Revision |
| Galzin | zinc acetate | Capsule; Oral | Teva | Manufacturing Change or Addition |
| Glimepiride | glimepiride | Tablet; Oral | Hikma Pharms | Approval |
| K-Tab | potassium chloride | Tablet, Extended Release; Oral | Abbvie | Manufacturing Change or Addition |
| Norethindrone | norethindrone | Tablet; Oral | Haupt Pharma | Approval |
| Orap | pimozide | Tablet; Oral | Teva | Manufacturing Change or Addition |
| Potassium Chloride | potassium chloride | Tablet, Extended Release; Oral | Abbvie | Manufacturing Change or Addition |
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