Skip to contentApplication 218171
- Type
- NDA
- Sponsor
- XCOVERY
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENSACOVE | ENSARTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | Yes | No |
| 002 | ENSACOVE | ENSARTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85193 | SUPPL | 2026-03-02 |
| 85192 | SUPPL | 2026-03-02 |
| 84734 | SUPPL | 2026-01-12 |
| 84725 | SUPPL | 2026-01-09 |
| 80855 | ORIG | 2025-01-16 |
| 80647 | ORIG | 2024-12-19 |
| 80629 | ORIG | 2024-12-19 |