What's New on the FDA Drugs Site
February 4, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
New and Generic Drug Approvals
February 3, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Bivalirudin | bivalirudin | Injectable; Injection | Hospira Inc | Tentative Approval |
| Eligard | leuprolide acetate | Injectable;Subcutaneous | Tolmar Therap | Manufacturing Change or Addition |
| Epaned Kit | enalapril maleate | For Solution;Oral | Silvergate Pharms | Manufacturing Change or Addition |
| Extraneal | icodextrin | Solution;Intraperitoneal | Baxter Hlthcare | Manufacturing Change or Addition |
| Glycopyrrolate | glycopyrrolate | Tablet;Oral | Stason Pharms | Approval |
| Lamivudine; Zidovudine | lamivudine; zidovudine | Tablet; Oral | Hetero Labs Ltd V | Approval |
| Lunesta | eszopiclone | Tablet;Oral | Sunovion Pharms Inc | Labeling Revision |
| Modafinil | modafinil | Tablet; Oral | Apotex | Approval |
| Pepcid | famotidine | Tablet;Oral | Marathon Pharms | Labeling Revision |
| Primaquine Phosphate | primaquine phosphate | Tablet; Oral | Alvogen Inc | Approval |
| Selfemra | fluoxetine | Tablet;Oral | Teva Pharms Usa | Approval |
| Trusopt | dorzolamide hydrochloride | Solution/Drops;Ophthalmic | Merck | Labeling Revision |
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