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Application 761279
- Type
- BLA
- Sponsor
- ELI LILLY AND CO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMVOH | MIRIKIZUMAB-MRKZ | VIAL; SINGLE-USE | 300MG/15ML | No | No |
| 002 | OMVOH | MIRIKIZUMAB-MRKZ | INJECTABLE;SUBCUTANEOUS | 100MG/ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83917 | SUPPL | 2025-10-27 |
| 83916 | SUPPL | 2025-10-27 |
| 83914 | SUPPL | 2025-10-24 |
| 83913 | SUPPL | 2025-10-24 |
| 80880 | SUPPL | 2025-01-21 |
| 80879 | SUPPL | 2025-01-21 |
| 80857 | SUPPL | 2025-01-16 |
| 80856 | SUPPL | 2025-01-16 |
| 78318 | SUPPL | 2024-04-30 |
| 78311 | SUPPL | 2024-04-30 |
| 76666 | ORIG | 2023-11-27 |
| 75976 | ORIG | 2023-10-27 |
| 75964 | ORIG | 2023-10-27 |