Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761104
Company: INNATE PHARMA
Company: INNATE PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUMOXITI | MOXETUMOMAB PASUDOTOX-TDFK | 1MG/VIAL | 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 |
---|---|---|---|---|---|---|---|
09/13/2018 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761104Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761104Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/20/2020 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761104Orig1s003ltr.pdf | |
01/25/2019 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761104Orig1s001Ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/20/2020 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf | |
08/20/2020 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf | |
08/20/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761104s003lbl.pdf | |
01/25/2019 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s001lbl.pdf | |
01/25/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761121s001lbl.pdf | |
09/13/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf |