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

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

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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 is not available on this site.
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	Url
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