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Application 219921
- Type
- NDA
- Sponsor
- AVYXA HOLDINGS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | KYXATA | CARBOPLATIN | SOLUTION;INTRAVENOUS | 20MG/2ML (10MG/ML) | Yes | No |
| 002 | KYXATA | CARBOPLATIN | SOLUTION;INTRAVENOUS | 80MG/8ML (10MG/ML) | Yes | Yes |
| 003 | KYXATA | CARBOPLATIN | SOLUTION;INTRAVENOUS | 500MG/50ML (10MG/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83092 | ORIG | 2025-08-12 |
| 83069 | ORIG | 2025-08-11 |