New and Generic Drug Approvals
October 7, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ambien | zolpidem tartrate | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Ambien Cr | zolpidem tartrate | Tablet, Extended Release;Oral | Sanofi Aventis Us | Labeling Revision |
| Benicar | olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Manufacturing Change or Addition |
| Budesonide | budesonide | Solution;Topical Foam | Salix Pharms | Approval |
| Darunavir Ethanolate | darunavir ethanolate | Tablet;Oral | Hetero Labs Unit Iii | Tentative Approval |
| Lo Minastrin Fe | ethinyl estradiol; norethindrone acetate | Tablet, Chewable, Tablet;Oral | Warner Chilcott | Manufacturing Change or Addition |
| Otrexup | methotrexate | Solution;Subcutaneous | Antares Pharma Inc | Manufacturing Change or Addition |
| Torisel | temsirolimus | Solution;Intravenous | Pf Prism Cv | Labeling Revision |
| Zoladex | goserelin acetate | Implant;Implantation | Astrazeneca | Labeling Revision |
| Zoladex | goserelin acetate | Implant;Implantation | Astrazeneca | Labeling Revision |
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