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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761100
Company: SAMSUNG BIOEPIS CO LTD

Products on BLA 761100

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONTRUZANT	TRASTUZUMAB-DTTB	150MG	POWDER;IV (INFUSION)	Prescription	None	No	No
ONTRUZANT	TRASTUZUMAB-DTTB	420MG	POWDER;IV (INFUSION)	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761100

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/18/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761100s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761100Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761100Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/2026	SUPPL-30	Supplement		Label is not available on this site.
12/05/2025	SUPPL-28	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761100Orig1s028ltr.pdf
02/28/2025	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761100Orig1s025correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761100Orig1s025correctedltr_.pdf
03/19/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761100Orig1s005Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761100Orig1s005ltr.pdf

Labels for BLA 761100

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-25	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761100Orig1s025correctedlbl.pdf
03/19/2020	SUPPL-5	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761100Orig1s005Lbl.pdf
01/18/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761100s000lbl.pdf

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