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Application 210852
- Type
- NDA
- Sponsor
- AVYXA HOLDINGS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FRINDOVYX | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/ML (500MG/ML) | Yes | Yes |
| 002 | FRINDOVYX | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/2ML (500MG/ML) | Yes | Yes |
| 003 | FRINDOVYX | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/4ML (500MG/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83048 | SUPPL | 2025-08-05 |
| 83035 | SUPPL | 2025-08-04 |
| 81090 | SUPPL | 2025-02-06 |
| 80986 | SUPPL | 2025-02-05 |
| 77886 | ORIG | 2024-03-21 |
| 74468 | ORIG | 2023-06-09 |
| 74462 | ORIG | 2023-06-08 |