Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761081
Company: PFIZER INC

Products on BLA 761081

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761081

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/11/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761081Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761081Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2025	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761081s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761081Orig1s017ltr.pdf
05/07/2020	SUPPL-6	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761081Orig1s006ltr.pdf
01/24/2020	SUPPL-2	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761081Orig1s002ltr.pdf

Labels for BLA 761081

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2025	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761081s017lbl.pdf
03/11/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf