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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761451
Company: ASTRAZENECA AB

Products on BLA 761451

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SAPHNELO	ANIFROLIMAB-FNIA	300MG/2ML (150MG/ML	VIAL; SINGLE-USE	Prescription	None	No	No
SAPHNELO	ANIFROLIMAB-FNIA	120MG/0.8ML	INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761451

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/24/2026	ORIG-1	Approval		N/A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761451Orig1s000ltr.pdf

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