Application 761183
- Type
- BLA
- Sponsor
- PROVENTION BIO INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TZIELD | TEPLIZUMAB-MZWV | INJECTABLE;INJECTION | 2MG/2ML(1MG/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 73650-316 | TZIELD | teplizumab-mzwv | Provention Bio, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85741 | SUPPL | 2026-04-24 |
| 85731 | SUPPL | 2026-04-21 |
| 73089 | ORIG | 2023-01-05 |
| 72905 | ORIG | 2022-12-15 |
| 72666 | ORIG | 2022-11-22 |
| 72659 | ORIG | 2022-11-21 |