New and Generic Drug Approvals
August 25, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bacitracin | bacitracin | Injectable;Injection | Xellia Pharms Aps | Approval |
| Buspirone Hydrochloride | buspirone hydrochloride | Tablet;Oral | Strides Arcolab Ltd | Approval |
| Diabeta | glyburide | Tablet;Oral | Sanofi Aventis Us | Manufacturing Change or Addition |
| Faslodex | fulvestrant | Injectable;Intramuscular | Astrazeneca | Manufacturing Change or Addition |
| Invega Sustenna | paliperidone palmitate | Suspension, Extended Release;Intramuscular | Janssen Pharms | Manufacturing Change or Addition |
| Kabiven and Perikabiven | amino acids;electrolytes;dextrose;lipid | Injectable;Injection | Fresenius Kabi | Approval |
| Membraneblue | trypan blue | Solution;Ophthalmic | Dorc | Manufacturing Change or Addition |
| Oxacillin Sodium | oxacillin sodium | Injectable;Injection | Agila Speclts | Approval |
| Tafinlar | dabrafenib mesylate | Capsule;Oral | Glaxosmithkline | Manufacturing Change or Addition |
| Tricor | fenofibrate | Tablet;Oral | Abbvie | Manufacturing Change or Addition |
| Visionblue | trypan blue | Solution;Ophthalmic | Dorc | Manufacturing Change or Addition |
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