New and Generic Drug Approvals
November 16, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Choline C-11 | choline c-11 | Injectable;Intravenous | Mcprf | Manufacturing Change or Addition |
| Fiorinal W/Codeine | aspirin; butalbital; caffeine; codeine phosphate | Capsule;Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Injectafer | ferric carboxymaltose | Injectable;Intravenous | Luitpold | Manufacturing Change or Addition |
| Morphine Sulfate | morphine sulfate | Solution;Intramuscular, Intravenous | Bd Rx | Manufacturing Change or Addition |
| Resectisol In Plastic Container | mannitol | Solution;Irrigation | B Braun | Manufacturing Change or Addition |
| Zytiga | abiraterone acetate | Tablet;Oral | Janssen Biotech | Manufacturing Change or Addition |
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