Application 761498
- 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 |
|---|
| 761498 | 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;IV (INFUSION) | 80MG/4ML(20MG/ML) | No | No |
| 002 | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;IV (INFUSION) | 200MG/10ML(20MG/ML) | No | No |
| 003 | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;IV (INFUSION) | 400MG/20ML(20MG/ML) | No | No |
| 004 | AVTOZMA | TOCILIZUMAB-ANOH | INJECTABLE;SUBCUTANEOUS | 162MG/20ML(20MG/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 |
|---|
| 85025 | ORIG | 2026-02-12 |
| 84818 | ORIG | 2026-01-22 |
| 84793 | ORIG | 2026-01-21 |
| 84792 | ORIG | 2026-01-21 |