What's New on the FDA Drugs Site
March 18, 2013
- Drug Firm Annual Registration Status Download File (updated)
- FAERS Quarterly Data Files Documentation
- National Drug Code Directory (updated)
- Resources and Tools for Preventing Surgical Fires (updated)
New and Generic Drug Approvals
March 15, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cetrotide | cetrorelix | Injectable; Injection | Emd Serono | Manufacturing Change or Addition |
| Daptomycin | daptomycin | Injectable; Injection | Hospira Inc | Tentative Approval |
| Freamine 8.5% | amino acids | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Freamine Hbc 6.9% | amino acids | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Freamine Ii 8.5% | amino acids | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Freamine Iii 10% | amino acids | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Freamine Iii 3% W/ Electrolytes | amino acids; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Freamine Iii 8.5% | amino acids | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Freamine Iii 8.5% W/ Electrolytes | amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Levalbuterol Hydrochloride | levalbuterol hydrochloride | Solution; Inhalation | Dey | Approval |
| Maxipime | cefepime hydrochloride | Injectable; Injection | Hospira Inc | Labeling Revision |
| Oxytrol | oxybutynin | Film, Extended Release; Transdermal | Watson Labs (Utah) | Manufacturing Change or Addition |
| Ultra-Technekow Fm | technetium tc-99m sodium pertechnetate generator | Solution; Injection, Oral | Mallinckrodt | Manufacturing Change or Addition |
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