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FDA approval · 2025-11-25

FDA Approved: IRBESARTAN — Supplemental Application (NorthStar RxLLC)

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Summary

FDA approved a supplemental application for irbesartan filed by NorthStar RxLLC under ANDA 202254, authorizing changes to the product's approval.

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Diseases / indications

Drugs mentioned

  • Irbesartan (irbesartan)

Snippet

SUPPL AP for IRBESARTAN (IRBESARTAN)