Application 761406
- Type
- BLA
- Sponsor
- BIOCON BIOLOGICS INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761406 | Yesintek | ustekinumab-kfce | 351(k) Interchangeable | Rx | 2026-08-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | YESINTEK | USTEKINUMAB-KFCE | INJECTABLE;INJECTION | 45MG/0.5ML | No | No |
| 002 | YESINTEK | USTEKINUMAB-KFCE | INJECTABLE;INJECTION | 90MG/ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84720 | SUPPL | 2026-01-08 |
| 84719 | SUPPL | 2026-01-08 |
| 84717 | ORIG | 2026-01-08 |
| 82719 | ORIG | 2025-06-30 |
| 82718 | ORIG | 2025-06-30 |
| 82137 | ORIG | 2025-05-05 |
| 82275 | ORIG | 2025-04-30 |
| 80468 | ORIG | 2024-12-02 |
| 80454 | ORIG | 2024-11-29 |