FDA
approval
· 2025-11-12
FDA Tentative Approval: FLUOROURACIL — Supplemental Application (Gland Pharma Limited)
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…
Upgrade for the full analysis, importance score, and drug timeline.
Diseases / indications
Drugs mentioned
Snippet
SUPPL TA for FLUOROURACIL (FLUOROURACIL)