Skip to contentApplication 219008
- Type
- NDA
- Sponsor
- JANSSEN BIOTECH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LAZCLUZE | LAZERTINIB MESYLATE | TABLET;ORAL | EQ 80MG BASE | Yes | No |
| 002 | LAZCLUZE | LAZERTINIB MESYLATE | TABLET;ORAL | EQ 240MG BASE | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85841 | SUPPL | 2026-05-05 |
| 85817 | SUPPL | 2026-05-04 |
| 84140 | SUPPL | 2025-11-12 |
| 84130 | SUPPL | 2025-11-10 |
| 83108 | SUPPL | 2025-08-18 |
| 79628 | ORIG | 2024-09-16 |
| 79450 | ORIG | 2024-08-20 |
| 79439 | ORIG | 2024-08-20 |