What's New on the FDA Drugs Site
July 2, 2012
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
- Drug Shortages: Current Drug Shortages: Viaspan Cold Storage Solution (updated)
- Drug Shortages: Current Drug Shortages: Citric Acid; Gluconolactone; Magnesium Carbonate Solution; Irrigation (new)
- Guidance for Industry:
- National Drug Code Directory (updated)
New and Generic Drug Approvals
June 29, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cosyntropin | cosyntropin | Injectable; Injection | Innopharma Inc | Approval |
| Glimepiride | glimepiride | Tablet; Oral | Micro Labs Usa | Approval |
| Glimepiride | glimepiride | Tablet; Oral | Aurobindo Pharma Ltd | Approval |
| Guanfacine Hydrochloride | guanfacine hydrochloride | Tablet, Extended Release; Oral | Actavis Elizabeth | Tentative Approval |
| Hydrocodone Polistirex and Chlorpheniramne Polistirex | chlorpheniramine polistirex; hydrocodone polistirex | Suspension, Extended Release; Oral | Cornerstone Therap | Approval |
| Levocetirizine Dihydrochloride | levocetirizine dihydrochloride | Tablet; Oral | Hetero Labs Ltd Iii | Approval |
| Lithium Carbonate | lithium carbonate | Tablet, Extended Release; Oral | Mylan Pharms Inc | Approval |
| Lopinavir; Ritonavir | lopinavir; ritonavir | Solution; Oral | Cipla Limited | Tentative Approval |
| Promethazine Hydrochloride and Codeine Phosphate | codeine phosphate; promethazine hydrochloride | Syrup; Oral | Tris Pharma Inc | Approval |
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