Application 212443
- Type
- ANDA
- Sponsor
- ENCUBE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KETOCONAZOLE | KETOCONAZOLE | CREAM;TOPICAL | 2% | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21922-025 | Ketoconazole | Ketoconazole Cream, 2% | Encube Ethicals Private Limited | ANDA | Current |
| 50090-6046 | Ketoconazole | Ketoconazole Cream, 2% | A-S Medication Solutions | ANDA | Current |
| 68071-2847 | Ketoconazole | Ketoconazole Cream, 2% | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-8233 | Ketoconazole | Ketoconazole Cream, 2% | Preferred Pharmaceuticals Inc. | ANDA | Current |