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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761091
Company: CELLTRION INC

Products on BLA 761091

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HERZUMA	TRASTUZUMAB-PKRB	420MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761091

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2018	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761091Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761091Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-35	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761091s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761091Orig1s035ltr.pdf
11/13/2024	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761091s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761091Orig1s033ltr.pdf
05/16/2019	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761091Orig1s001, s002ltr.pdf
05/16/2019	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761091Orig1s001, s002ltr.pdf

Labels for BLA 761091

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/2025	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761091s035lbl.pdf
05/22/2025	SUPPL-35	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761091s035lbl.pdf
11/13/2024	SUPPL-33		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761091s033lbl.pdf
05/16/2019	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf
05/16/2019	SUPPL-1	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761091s001s002lbl.pdf
12/14/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf

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