Skip to contentApplication 761399
- 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 |
|---|
| 761399 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMLYCLO | OMALIZUMAB-IGEC | INJECTABLE;INJECTION | 75MG/0.5ML | No | No |
| 002 | OMLYCLO | OMALIZUMAB-IGEC | INJECTABLE;INJECTION | 150MG/ML | No | No |
| 003 | OMLYCLO | OMALIZUMAB-IGEC | INJECTABLE;INJECTION | 300MG/2ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85555 | ORIG | 2026-03-27 |
| 84728 | SUPPL | 2026-01-09 |
| 84727 | SUPPL | 2026-01-09 |
| 81481 | ORIG | 2025-03-07 |
| 81479 | ORIG | 2025-03-07 |