Application 761347
- Type
- BLA
- Sponsor
- GENENTECH INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TECENTRIQ HYBREZA | ATEZOLIZUMAB AND HYALURONIDASE-TQJS | INJECTABLE;INJECTION | 125MG;2000UNITS PER ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85981 | SUPPL | 2026-05-19 |
| 85947 | SUPPL | 2026-05-18 |
| 85908 | SUPPL | 2026-05-13 |
| 84306 | SUPPL | 2025-11-25 |
| 84301 | SUPPL | 2025-11-25 |
| 84300 | SUPPL | 2025-11-25 |
| 84192 | SUPPL | 2025-11-18 |
| 83651 | SUPPL | 2025-10-03 |
| 83142 | SUPPL | 2025-08-20 |
| 83140 | SUPPL | 2025-08-19 |
| 81921 | ORIG | 2025-04-10 |
| 79623 | ORIG | 2024-09-16 |
| 79595 | ORIG | 2024-09-16 |