Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761198
Company: BIO-THERA SOLUTIONS LTD
Company: BIO-THERA SOLUTIONS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVZIVI | BEVACIZUMAB-TNJN | 100MG/4ML(25MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| AVZIVI | BEVACIZUMAB-TNJN | 400MG/16ML(25MG/ML) | INJECTABLE;INJECTION | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 12/06/2023 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761198s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761198Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761198Orig1s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/06/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761198s000lbl.pdf |