FDA Approval for TZIELD issued to PROVENTION BIO INC
$PRVB
Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761183
Company: PROVENTION BIO INC
Company: PROVENTION BIO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TZIELD | TEPLIZUMAB-MZWV | 2MG/2ML(1MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/17/2022 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761183Orig1s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761183Orig1s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/20/2026 | SUPPL-13 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761183Orig1s013ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/17/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183Orig1s000lbl.pdf |