New and Generic Drug Approvals
New and Generic Drug Approvals
August 6, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Asmanex Hfa | mometasone furoate | Aerosol, Metered;Inhalation | Merck Sharp Dohme | Manufacturing Change or Addition |
| Bio-Tropin | somatropin recombinant | Injectable;Injection | Ferring | Manufacturing Change or Addition |
| Climara | estradiol | Film, Extended Release;Transdermal | Bayer Hlthcare | Manufacturing Change or Addition |
| Commit | nicotine polacrilex | Troche/Lozenge;Oral | Glaxosmithkline Cons | Labeling Revision |
| Dulera | formoterol fumarate; mometasone furoate | Aerosol, Metered;Inhalation | Merck Sharp Dohme | Manufacturing Change or Addition |
| Nicoderm Cq | nicotine | Film, Extended Release;Transdermal | Sanofi Aventis Us | Labeling Revision |
| Solu-Medrol | methylprednisolone sodium succinate | Injectable;Injection | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Varithena | polidocanol | Solution;Intravenous | Provensis | Manufacturing Change or Addition |
| Zomacton | somatropin recombinant | Injectable;Injection | Ferring | Manufacturing Change or Addition |
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