Application 075496
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 2.5MG | No | No |
| 002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-442 | Enalapril Maleate | enalapril maleate | Northstar RxLLC | ANDA | Current |
| 16714-443 | Enalapril Maleate | enalapril maleate | Northstar RxLLC | ANDA | Current |
Documents
| Document | Submission type | Date |
|---|
| 8693 | ORIG | 2004-06-03 |