What's New on the FDA Drugs Site
September 6, 2012
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
New and Generic Drug Approvals
September 5, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amlodipine Besylate; Benazepril Hydrochloride | amlodipine besylate; benazepril hydrochloride | Capsule; Oral | Aurobindo Pharma Ltd | Approval |
| Declomycin | demeclocycline hydrochloride | Tablet; Oral | Corepharma | Labeling Revision |
| Trilipix | choline fenofibrate | Capsule, Delayed Release; Oral | Abbott Labs | Labeling Revision |
| Trilipix | choline fenofibrate | Capsule, Delayed Release; Oral | Abbott Labs | Manufacturing Change or Addition |
| Ziprasidone Hydrochloride | ziprasidone hydrochloride | Capsule; Oral | Wockhardt Ltd | Approval |
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