Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761115
Company: IMMUNOMEDICS INC
Company: IMMUNOMEDICS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRODELVY | SACITUZUMAB GOVITECAN-HZIY | 180MG | 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 |
---|---|---|---|---|---|---|---|
04/22/2020 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761115Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761115Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/22/2024 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761115s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761115Orig1s058ltr.pdf | |
01/06/2023 | SUPPL-36 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761115Orig1s036ltr.pdf |
02/03/2023 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761115Orig1s035ltr.pdf | |
12/05/2022 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115Orig1s031Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761115Orig1s031ltr.pdf | |
06/03/2022 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761115Orig1s023ltr.pdf | |
04/07/2021 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s005, s013ltr.pdf | |
04/13/2021 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s009ltr.pdf | |
04/07/2021 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761115Orig1s005, s013ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/22/2024 | SUPPL-58 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761115s058lbl.pdf | |
02/03/2023 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761115s035lbl.pdf | |
12/05/2022 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115Orig1s031Lbl.pdf | |
06/03/2022 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761115s023lbl.pdf | |
04/13/2021 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf | |
04/07/2021 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf | |
04/07/2021 | SUPPL-5 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s005s013lbl.pdf | |
04/22/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf |