What's New on the FDA Drugs Site
April 16, 2014
- New Safety Measures Announced for Extended-release and Long-acting Opioids (updated)
- Public Notification: S.W.A.G Contains Hidden Drug Ingredient
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Guidance for Industry:
New and Generic Drug Approvals
April 15, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Eligard | leuprolide acetate | Injectable;Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Eszopiclone | eszopiclone | Tablet;Oral | Dr Reddys Labs Ltd | Approval |
| Eszopiclone | eszopiclone | Tablet;Oral | Roxane | Approval |
| Eszopiclone | eszopiclone | Tablet;Oral | Glenmark Generics | Approval |
| Excedrin (Migraine) | acetaminophen; aspirin; caffeine | Tablet;Oral | Novartis | Labeling Revision |
| Neurontin | gabapentin | Solution;Oral | Parke Davis | Manufacturing Change or Addition |
| Ramipril | ramipril | Capsule;Oral | Accord Hlthcare Inc | Approval |
| Sitagliptin Phosphate | sitagliptin phosphate | Tablet;Oral | Watson Labs Inc | Tentative Approval |
| Tanzeum | albiglutide | Injectable;Injection | Glaxosmithkline Llc | Approval |
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