Application 217150
- Type
- NDA
- Sponsor
- SANDOZ
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/5ML (100MG/ML) | Yes | Yes |
| 002 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/10ML (100MG/ML) | Yes | Yes |
| 003 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/20ML (100MG/ML) | Yes | Yes |
Documents
| Document | Submission type | Date |
|---|
| 80792 | SUPPL | 2025-01-02 |
| 80788 | SUPPL | 2025-01-02 |
| 78087 | ORIG | 2024-04-08 |
| 75440 | ORIG | 2023-09-13 |
| 75418 | ORIG | 2023-09-13 |