What's New on the FDA Drugs Site
August 20, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Manual of Policies and Procedures (MAPP) 5240.5 ANDA Suitability Petitions (PDF - 45KB)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
August 19, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Amitiza | lubiprostone | Capsule; Oral | Sucampo Pharms | Manufacturing Change or Addition |
| Colyte | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Labeling Revision |
| Colyte With Flavor Packs | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Labeling Revision |
| Colyte-Flavored | polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous | For Solution; Oral | Meda Pharms | Labeling Revision |
| Erythrocin | erythromycin lactobionate | Injectable; Injection | Hospira | Approval |
| Januvia | sitagliptin phosphate | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
| Juvisync | simvastatin; sitagliptin phosphate | Tablet; Oral | Merck Sharp Dohme | Labeling Revision |
| Urso 250 | ursodiol | Tablet; Oral | Aptalis Pharma Us | Approval |
| Urso Forte | ursodiol | Tablet; Oral | Aptalis Pharma Us | Approval |
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