New and Generic Drug Approvals
October 2, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adenosine | adenosine | Injectable; Injection | Akorn Inc | Approval |
| Hetlioz | tasimelteon | Capsule;Oral | Vanda Pharms Inc | Approval |
| Monoket | isosorbide mononitrate | Tablet;Oral | Kremers Urban Pharms | Labeling Revision |
| Nitro-Dur | nitroglycerin | Film, Extended Release;Transdermal | Merck Sharp Dohme | Labeling Revision |
| Nitroglycerin In Dextrose 5% | nitroglycerin | Injectable;Injection | Baxter Hlthcare | Labeling Revision |
| Pitocin | oxytocin | Injectable;Injection | Par Sterile Products | Labeling Revision |
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