Skip to contentApplication 216984
- Type
- NDA
- Sponsor
- SHORLA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TEPYLUTE | THIOTEPA | SOLUTION;INTRAVENOUS | 15MG/1.5ML (10MG/ML) | Yes | Yes |
| 002 | TEPYLUTE | THIOTEPA | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84373 | SUPPL | 2026-04-20 |
| 84374 | SUPPL | 2026-01-23 |
| 82187 | ORIG | 2025-05-15 |
| 81378 | SUPPL | 2025-02-27 |
| 81377 | SUPPL | 2025-02-27 |
| 78903 | ORIG | 2024-06-26 |