Application 761452
- Type
- BLA
- Sponsor
- ACCORD BIOPHARMA INC.
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761452 | Immgolis | golimumab-sldi | 351(k) Interchangeable | Rx | 2026-07-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IMMGOLIS | GOLIMUMAB-SLDI | INJECTION;SOLUTION | 50MG/0.5ML | No | No |
| 002 | IMMGOLIS | GOLIMUMAB-SLDI | INJECTION;SOLUTION | 100MG/1ML | No | No |
| 003 | IMMGOLIS INTRI | GOLIMUMAB-SLDI | INJECTION;SOLUTION | 50MG/4ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85960 | ORIG | 2026-05-19 |
| 85953 | ORIG | 2026-05-18 |
| 85922 | ORIG | 2026-05-15 |