What's New on the FDA Drugs Site
August 23, 2016
- Bioequivalence Recommendation for: Fidaxomicin (PDF - 26KB)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
August 22, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Banzel | rufinamide | Tablet;Oral | Eisai Inc | Manufacturing Change or Addition |
| Loestrin 24 Fe | ethinyl estradiol; norethindrone acetate | Tablet;Oral | Warner Chilcott | Labeling Revision |
| Movantik | naloxegol oxalate | Tablet;Oral | Astrazeneca Pharms | Labeling Revision |
| Nitroglycerin In Dextrose 5% | nitroglycerin | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Palonosetron Hydrochloride | palonosetron hydrochloride | Injectable;Injection | Exela Pharma Scs Llc | Approval |
| Trecator | ethionamide | Tablet;Oral | Wyeth Pharms Inc | Labeling Revision |
| Xarelto | rivaroxaban | Tablet;Oral | Janssen Pharms | Manufacturing Change or Addition |
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Wednesday, August 24, 2016
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