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FDA approval · 2025-11-12

FDA Tentative Approval: FLUOROURACIL — Supplemental Application (Gland Pharma Limited)

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Summary

FDA Tentative Approval for Fluorouracil from Gland Pharma Limited under an ANDA, indicating a pathway to U.S. market subject to regulatory terms. The approval i…

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Diseases / indications

Drugs mentioned

  • FLUOROURACIL (Fluorouracil)

Snippet

SUPPL TA for FLUOROURACIL (FLUOROURACIL)