What's New on the FDA Drugs Site
August 22, 2016
- 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 19, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Daytrana | methylphenidate | Film, Extended Release;Transdermal | Noven Pharms Inc | Labeling Revision |
| Doxylamine Succinate; Pyridoxine Hydrochloride | doxylamine succinate;pyridoxine hydrochloride | Tablet, Delayed Release;Oral | Actavis Labs Fl Inc | Approval |
| Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate | ethinyl estradiol; norethindrone acetate | Capsule;Oral | Apil | Labeling Revision |
| Patanol | olopatadine hydrochloride | Solution/Drops;Ophthalmic | Alcon | Manufacturing Change or Addition |
| Pitocin | oxytocin | Injectable;Injection | Par Sterile Products | Manufacturing Change or Addition |
| Rosuvastatin Calcium | rosuvastatin calcium | Unknown | Biocon Limited | Tentative Approval |
| Simponi Aria | golimumab | Injectable; Injection | Janssen Biotech | Labeling Revision |
| Sodium Sulfate; Potassium Sulfate; Magnesium Sulfate | sodium sulfate;potassium sulfate;magnesium sulfate | Unknown | Paddock Labs | Tentative Approval |
| Tegretol | carbamazepine | Suspension;Oral | Novartis | Manufacturing Change or Addition |
| Triferic | ferric pyrophosphate citrate | Solution;Iv (Infusion) | Rockwell Medical Inc | Manufacturing Change or Addition |
| Troxyca Er | oxycodone hydrochloride; naltrexone hydrochloride | Capsule;Oral | Pfizer Inc | Approval |
| Zoledronic Acid | zoledronic acid | Injectable;Iv (Infusion) | Gland Pharma Ltd | Approval |
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Tuesday, August 23, 2016
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