New and Generic Drug Approvals
November 17, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cutivate | fluticasone propionate | Lotion;Topical | Fougera Pharms | Manufacturing Change or Addition |
| Hepatamine 8% | amino acids | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Nucynta | tapentadol hydrochloride | Solution;Oral | Janssen Pharms | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Syringe | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Sylatron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Unasyn | ampicillin sodium; sulbactam sodium | Injectable;Injection | Pfizer | Labeling Revision |
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