New and Generic Drug Approvals
September 3, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Arthrotec | diclofenac sodium; misoprostol | Tablet, Delayed Release;Oral | Gd Searle Llc | Labeling Revision |
| Dextrose 25% | dextrose | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Dextrose 50% In Plastic Container | dextrose | Injectable;Injection | Hospira | Manufacturing Change or Addition |
| Digoxin | digoxin | Tablet;Oral | Mylan Pharms Inc | Manufacturing Change or Addition |
| Dorzolamide Hydrochloride and Timolol Maleate | dorzolamide hydrochloride;timolol maleate | Solution;Ophthalmic | Watson Labs Inc | Approval |
| Gatifloxacin | gatifloxacin | Solution;Ophthalmic | Hi-Tech Pharmacal | Approval |
| Milrinone Lactate | milrinone lactate | Injectable;Injection | Hospira Inc | Approval |
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