What's New on the FDA Drugs Site
April 14, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Current Drug Shortages Index (updated)
- National Drug Code Directory
New and Generic Drug Approvals
April 11, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Clopidogrel | clopidogrel | Tablet; Oral | Amneal Pharms | Approval |
| Fortaz In Plastic Container | ceftazidime sodium | Injectable;Injection | Covis Pharma | Manufacturing Change or Addition |
| 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 |
| Lidocaine Hydrochloride | lidocaine hydrochloride | Injectable; Injection | Agila Speclts | Approval |
| Ortho Evra | ethinyl estradiol; norelgestromin | Film, Extended Release;Transdermal | Janssen Pharms | Labeling Revision |
| Premarin | estrogens, conjugated | Tablet;Oral | Wyeth Pharms Inc | Manufacturing Change or Addition |
| Sporanox | itraconazole | Capsule;Oral | Janssen Pharms | Manufacturing Change or Addition |
| Vimpat | lacosamide | Solution;Oral | Ucb Inc | Manufacturing Change or Addition |
| Xyrem | sodium oxybate | Solution;Oral | Jazz Pharms | Efficacy Supplement with Clinical Data to Support |
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