Application 761467
- Type
- BLA
- Sponsor
- MERCK SHARP DOHME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KEYTRUDA QLEX | PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH | INJECTABLE;INJECTION | 395MG/4800UNITS(2.4ML) | No | No |
| 002 | KEYTRUDA QLEX | PEMBROLIZUMAB;BERAHYALURONIDASE ALFA-PMPH | INJECTABLE;INJECTION | 790MG/9600UNITS(4.8ML) | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85951 | SUPPL | 2026-05-18 |
| 85910 | SUPPL | 2026-05-13 |
| 85773 | SUPPL | 2026-04-28 |
| 85770 | SUPPL | 2026-04-27 |
| 85654 | SUPPL | 2026-04-08 |
| 85652 | SUPPL | 2026-04-07 |
| 85005 | SUPPL | 2026-02-12 |
| 85004 | SUPPL | 2026-02-12 |
| 84290 | SUPPL | 2025-11-25 |
| 84289 | SUPPL | 2025-11-25 |
| 84283 | SUPPL | 2025-11-24 |
| 83663 | ORIG | 2025-10-06 |
| 83662 | ORIG | 2025-10-06 |
| 83418 | ORIG | 2025-10-06 |
| 83417 | ORIG | 2025-10-06 |
| 83413 | ORIG | 2025-09-22 |
| 83412 | ORIG | 2025-09-22 |
| 83410 | ORIG | 2025-09-22 |
| 83409 | ORIG | 2025-09-22 |