Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761359
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENTYVIO | VEDOLIZUMAB | 300MG | INJECTABLE;INTRAVENOUS | Prescription | None | No | No |
ENTYVIO | VEDOLIZUMAB | 108MG/0.68ML | INJECTABLE;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
04/18/2024 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761359s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/18/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761359s000lbl.pdf |