New and Generic Drug Approvals
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Budesonide | budesonide | Spray, Metered;Nasal | Apotex Inc | Approval |
Hydromorphone Hydrochloride | hydromorphone hydrochloride | Tablet, Extended Release;Oral | Actavis Inc | Approval |
Lo-Blisovi Fe | norethindrone acetate;ethinyl estradiol;ferrous fumarate | Tablet;Oral | Lupin Ltd | Tentative Approval |
Olanzapine | olanzapine | Tablet, Orally Disintegrating;Oral | Mylan Pharms Inc | Approval |
Rayos | prednisone | Tablet, Delayed Release;Oral | Horizon Pharma | Manufacturing Change or Addition |
Tivicay | dolutegravir sodium | Tablet;Oral | Viiv Hlthcare | Labeling Revision |
Topicort | desoximetasone | Ointment;Topical | Taro Pharms North | Manufacturing Change or Addition |
Toprol-Xl | metoprolol succinate | Tablet, Extended Release;Oral | Astrazeneca | Manufacturing Change or Addition |
Zirgan | ganciclovir | Gel;Ophthalmic | Bausch and Lomb | Manufacturing Change or Addition |
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