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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761099
Company: PFIZER INC

Products on BLA 761099

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZIRABEV	BEVACIZUMAB-BVZR	100MG/4ML	INJECTABLE;INJECTION	Prescription	None	No	No
ZIRABEV	BEVACIZUMAB-BVZR	400MG/16ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761099

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/27/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761099s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761099Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761099Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2023	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761099s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761099Orig1s010ltr.pdf
02/09/2021	SUPPL-6	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761099s006lbl.pdf
02/09/2021	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761099s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761099Orig1s004ltr.pdf

Labels for BLA 761099

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2023	SUPPL-10	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761099s010lbl.pdf
02/09/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761099s006lbl.pdf
02/09/2021	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761099s004lbl.pdf
06/27/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761099s000lbl.pdf

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