What's New on the FDA Drugs Site
August 21, 2013
- CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
New and Generic Drug Approvals
August 20, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Dexilant | dexlansoprazole | Capsule, Delayed Release; Oral | Takeda Pharms | Labeling Revision |
| Oxytrol For Women | oxybutynin | Film, Extended Release; Transdermal | Msd Consumer | Manufacturing Change or Addition |
| Tecfidera | dimethyl fumarate | Capsule, Delayed Release; Oral | Biogen Idec Inc | Manufacturing Change or Addition |
| Ziana | clindamycin phosphate; tretinoin | Gel; Topical | Medicis | Manufacturing Change or Addition |
| Zosyn | piperacillin sodium; tazobactam sodium | Injectable; Injection | Wyeth Pharms Inc | Manufacturing Change or Addition |
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