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Biologic License Application (BLA): 761115
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
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