Application 761420
- Type
- BLA
- Sponsor
- CELLTRION INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761420 | Avtozma | tocilizumab-anoh | 351(k) Interchangeable | Rx | 2026-09-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;INTRAVENOUS | 80MG/4ML(20MG/ML) | No | No |
| 002 | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;INTRAVENOUS | 200MG/10ML(20MG/ML) | No | No |
| 003 | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;INTRAVENOUS | 400MG/20ML(20MG/ML) | No | No |
| 004 | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;SUBCUTANEOUS | 162MG/0.9ML | 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 |
|---|
| 84784 | SUPPL | 2026-01-20 |
| 84757 | SUPPL | 2026-01-15 |
| 84269 | ORIG | 2025-11-24 |
| 83001 | SUPPL | 2025-07-31 |
| 82989 | SUPPL | 2025-07-30 |
| 82988 | SUPPL | 2025-07-30 |
| 81174 | ORIG | 2025-02-07 |
| 80894 | ORIG | 2025-02-04 |