Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761121
Company: GENENTECH
Company: GENENTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
POLIVY | POLATUZUMAB VEDOTIN-PIIQ | 140MG/VIAL | POWDER;INTRAVENOUS | Prescription | None | No | No |
POLIVY | POLATUZUMAB VEDOTIN-PIIQ | 30MG/VIAL | POWDER;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
06/10/2019 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761121Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761121Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/18/2020 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761121Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/18/2020 | SUPPL-3 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121Orig1s003lbl.pdf | |
06/10/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s000lbl.pdf |
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