Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761065
Company: THERATECHNOLOGIES
Company: THERATECHNOLOGIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TROGARZO | IBALIZUMAB-UIYK | 150MG/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 |
---|---|---|---|---|---|---|---|
03/06/2018 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/TROGARZO_761065_TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/12/2023 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761065s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761065Orig1s020ltr.pdf | |
10/03/2022 | SUPPL-13 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761065s013lbl.pdf | |
04/22/2021 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761065s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761065Orig1s011ltr.pdf | |
04/17/2020 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761065s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761065Orig1s008ltr.pdf | |
05/30/2018 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/12/2023 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761065s020lbl.pdf | |
12/12/2023 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761065s020lbl.pdf | |
10/03/2022 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761065s013lbl.pdf | |
04/22/2021 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761065s011lbl.pdf | |
04/17/2020 | SUPPL-8 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761065s008lbl.pdf | |
04/17/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761065s008lbl.pdf | |
05/30/2018 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf | |
05/30/2018 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065s001lbl.pdf | |
03/06/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf |