Application 761371
- Type
- BLA
- Sponsor
- GENENTECH INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761371 | Ocrevus Zunovo | ocrelizumab and hyaluronidase-ocsq | 351(a) | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OCREVUS ZUNOVO | OCRELIZUMAB AND HYALURONIDASE-OCSQ | INJECTABLE;INJECTION | 40MG;1000UNITS PER ML | No | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83897 | ORIG | 2025-10-23 |
| 83155 | SUPPL | 2025-08-20 |
| 83154 | SUPPL | 2025-08-20 |
| 83141 | SUPPL | 2025-08-19 |
| 79635 | ORIG | 2024-09-16 |
| 79583 | ORIG | 2024-09-13 |