New and Generic Drug Approvals
September 9, 2014
September 9, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Argatroban In Sodium Chloride | argatroban | Injectable;Iv (Infusion) | Eagle Pharms | Labeling Revision |
| Iclusig | ponatinib hydrochloride | Tablet;Oral | Ariad | Manufacturing Change or Addition |
| Levocetirizine Dihydrochloride | levocetirizine dihydrochloride | Tablet;Oral | Sciegen Pharms Inc | Approval |
| Namenda Xr | memantine hydrochloride | Capsule, Extended Release;Oral | Forest Labs | Manufacturing Change or Addition |
| Tacrolimus | tacrolimus | Ointment;Topical | Fougera Pharms Inc | Approval |
| Ultratag | technetium tc-99m red blood cell kit | Injectable;Injection | Mallinckrodt | Manufacturing Change or Addition |
| Unithroid | levothyroxine sodium | Tablet;Oral | Stevens J | Manufacturing Change or Addition |
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