What's New on the FDA Drugs Site
May 23, 2013
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Preventing Surgical Fires: Initiative Partners (updated)
- Warning Letters 2013 (updated)
New and Generic Drug Approvals
May 22, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ciprodex | ciprofloxacin; dexamethasone | Suspension/Drops; Otic | Alcon Pharms Ltd | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.037% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.075% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.11% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.15% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.22% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Potassium Chloride 0.3% In Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; potassium chloride; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Tasigna | nilotinib hydrochloride monohydrate | Capsule; Oral | Novartis | Labeling Revision |
| Yervoy | ipilimumab | Injectable; Injection | Bristol Myers Squibb | Labeling Revision |
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