Application 761164
- Type
- BLA
- Sponsor
- BIOVERATIV THERAPEUTICS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ENJAYMO | SUTIMLIMAB-JOME | INJECTABLE;INJECTION | 1,100MG/22ML(50MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 80203-347 | Enjaymo | sutimlimab | Bioverativ U.S. LLC. | BLA | Current |
| 80203-347 | Enjaymo | sutimlimab-jome | Bioverativ U.S. LLC. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77437 | SUPPL | 2024-02-09 |
| 77436 | SUPPL | 2024-02-09 |
| 77435 | SUPPL | 2024-02-09 |
| 73298 | SUPPL | 2023-01-26 |
| 73297 | SUPPL | 2023-01-26 |
| 73296 | SUPPL | 2023-01-26 |
| 72426 | SUPPL | 2022-10-20 |
| 70401 | ORIG | 2022-03-04 |
| 70193 | ORIG | 2022-02-18 |
| 70095 | ORIG | 2022-02-04 |
| 70094 | ORIG | 2022-02-04 |