Application 761420
- Type
- BLA
- Sponsor
- CELLTRION INC
Purple Book Biologic Products#
| 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 | 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| AVTOZMA | TOCILIZUMAB | CELLTRION USA, Inc. | 581c288f-8015-40ef-a4c3-683c96db193d | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | BLA761420 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.