Application 217651
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/2.5ML (200MG/ML) | Yes | Yes |
| 002 | CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/5ML (200MG/ML) | Yes | Yes |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|
| 77849 | 0 | ORIG | 1 | 2024-03-18 | Cached in FDA.report object storage |
| 76764 | 0 | ORIG | 1 | 2023-12-12 | Cached in FDA.report object storage |
| 74646 | 0 | ORIG | 1 | 2023-06-28 | Cached in FDA.report object storage |