What's New on the FDA Drugs Site
February 13, 2013
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Electronic Common Technical Document (eCTD) Module 1 (updated)
- National Drug Code Directory (updated)
- Warning Letters 2013
New and Generic Drug Approvals
February 12, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Dextroamphetamine Saccharate; Amphetamine Aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate | dextroamphetamine saccharate; amphetamine aspartate; dextroamphetamine sulfate; amphetamine sulfate | Capsule, Extended Release; Oral | Barr Labs Inc | Approval |
| Fml | fluorometholone | Suspension/Drops; Ophthalmic | Allergan | Labeling Revision |
| Fml | fluorometholone | Ointment; Ophthalmic | Allergan | Labeling Revision |
| Fml Forte | fluorometholone | Suspension/Drops; Ophthalmic | Allergan | Labeling Revision |
| Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.45% | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 10,000 Units In Sodium Chloride 0.9% | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 12,500 Units In Sodium Chloride 0.9% | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Container | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.45% | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Heparin Sodium 5,000 Units In Sodium Chloride 0.9% | heparin sodium | Injectable; Injection | Hospira | Labeling Revision |
| Jenloga | clonidine hydrochloride | Tablet, Extended Release; Oral | Shionogi Inc | Labeling Revision |
| Kapvay | clonidine hydrochloride | Tablet, Extended Release; Oral | Shionogi Inc | Labeling Revision |
| Lexiva | fosamprenavir calcium | Tablet; Oral | Viiv Hlthcare | Labeling Revision |
| Lexiva | fosamprenavir calcium | Suspension; Oral | Viiv Hlthcare | Labeling Revision |
| Mafenide Acetate | mafenide acetate | Solution; Topical | Par Pharm Inc | Approval |
| Quetiapine Fumarate | quetiapine fumarate | Tablet; Oral | Alkem Labs Ltd | Approval |
| Totect | dexrazoxane hydrochloride | Injectable; Injection | Apricus Pharms | Manufacturing Change or Addition |
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