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Application 761263
- Type
- BLA
- Sponsor
- GENENTECH INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LUNSUMIO | MOSUNETUZUMAB-AXGB | INJECTABLE;INJECTION | 1MG/ML | No | No |
| 002 | LUNSUMIO | MOSUNETUZUMAB-AXGB | INJECTABLE;INJECTION | 30MG/30ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50242-142 | Lunsumio | Mosunetuzumab | Genentech, Inc. | BLA | Current |
| 50242-159 | Lunsumio | Mosunetuzumab | Genentech, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84693 | SUPPL | 2026-01-06 |
| 84692 | SUPPL | 2026-01-06 |
| 84520 | SUPPL | 2025-12-23 |
| 80431 | SUPPL | 2024-11-26 |
| 80333 | SUPPL | 2024-11-25 |
| 73446 | ORIG | 2023-02-09 |
| 73026 | ORIG | 2022-12-23 |
| 73018 | ORIG | 2022-12-23 |
| 73017 | ORIG | 2022-12-23 |