New and Generic Drug Approvals
April 24, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Delflex W/ Dextrose 1.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 1.5% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 2.5% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Labeling Revision |
| Desoximetasone | desoximetasone | Ointment;Topical | Versapharm Inc | Approval |
| Provigil | modafinil | Tablet;Oral | Cephalon | Manufacturing Change or Addition |
| Rebif | interferon beta-1a | Syringe | Serono Inc | Labeling Revision |
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