What's New on the FDA Drugs Site
January 27, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory
- Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between July – September 2013
New and Generic Drug Approvals
January 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 | Manufacturing Change or Addition |
| Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| 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 | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| 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 | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | Solution;Intraperitoneal | Fresenius Medcl | Manufacturing Change or Addition |
| 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 | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.11% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 10% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.11% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 2.5% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 3.3% and Sodium Chloride 0.3% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.11% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.2% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.33% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.45% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dextrose 5% and Sodium Chloride 0.9% In Plastic Container | dextrose; sodium chloride | Injectable;Injection | B Braun | Manufacturing Change or Addition |
| Dilantin | phenytoin sodium | Injectable;Injection | Parke Davis | Labeling Revision |
| Dilantin-125 | phenytoin | Suspension;Oral | Parke Davis | Labeling Revision |
| Dilantin-30 | phenytoin | Suspension;Oral | Parke Davis | Labeling Revision |
| Forteo | teriparatide recombinant human | Injectable;Subcutaneous | Lilly | Manufacturing Change or Addition |
| Humalog | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 50/50 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Kwikpen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Mix 75/25 Pen | insulin lispro protamine recombinant; insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humatrope | somatropin recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Simponi | golimumab | Injectable; Injection | Centocor Ortho Biotech Inc | Labeling Revision |
| Zyvox | linezolid | Tablet;Oral | Pharmacia and Upjohn | Labeling Revision |
| Zyvox | linezolid | Injectable;Injection | Pharmacia and Upjohn | Labeling Revision |
| Zyvox | linezolid | For Suspension;Oral | Pharmacia and Upjohn | Labeling Revision |
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