What's New on the FDA Drugs Site
March 19, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey
- Manual of Policies and Procedures (MAPP) 4301.1 Office of Medical Policy - Program Description (PDF - 154KB)
- National Drug Code Directory (updated)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
March 18, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Doxorubicin Hydrochloride | doxorubicin hydrochloride | Injectable; Injection | Sagent Pharms | Approval |
| Doxycycline | doxycycline | For Suspension; Oral | Lupin Ltd | Approval |
| Exalgo | hydromorphone hydrochloride | Tablet, Extended Release; Oral | Mallinckrodt Inc | Labeling Revision |
| Rabeprazole Sodium | rabeprazole sodium | Tablet, Delayed Release; Oral | Lupin Ltd | Tentative Approval |
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