What's New on the FDA Drugs Site
January 30, 2014
- 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 (updated)
- National Drug Code Directory
New and Generic Drug Approvals
January 29, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Chorionic Gonadotropin | gonadotropin, chorionic | Injectable;Injection | Fresenius Kabi Usa | Manufacturing Change or Addition |
| Diclegis | doxylamine succinate; pyridoxine hydrochloride | Tablet, Delayed Release;Oral | Duchesnay | Manufacturing Change or Addition |
| Rapamune | sirolimus | Tablet;Oral | Pf Prism Cv | Manufacturing Change or Addition |
| Retin-A Micro | tretinoin | Gel;Topical | Valeant Intl | Manufacturing Change or Addition |
| Sumatriptan Succinate | sumatriptan succinate | Injectable; Injection | Dr Reddys Labs Inc | Approval |
| Topamax | topiramate | Tablet;Oral | Janssen Pharms | Labeling Revision |
| Topamax | topiramate | Capsule;Oral | Janssen Pharms | Labeling Revision |
| Topamax Sprinkle | topiramate | Capsule;Oral | Janssen Pharms | Labeling Revision |
| Vandazole | metronidazole | Gel;Vaginal | Teva Pharms | Manufacturing Change or Addition |
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