Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761382
Company: SANDOZ INC

Products on BLA 761382

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENZEEVU	AFLIBERCEPT-ABZV	2MG(0.05ML of 40MG/ML)	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761382

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761382s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761382Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761382s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761382Orig1s003ltr.pdf

Labels for BLA 761382

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761382s003lbl.pdf
08/09/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761382s000lbl.pdf