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Jul 8, 2026Regulatory decision

Amneal wins FDA approval for methylergonovine maleate labeling supplement

FDA approved a labeling change (Supplement 9) for Amneal's generic methylergonovine maleate tablets.

This week's only update involves a regulatory label action on an approved generic product.

  • Amneal Pharms received FDA approval for a labeling supplement (Supplement 9) to its 0.2mg methylergonovine maleate oral tablet under ANDA211483, with the submission status marked as approved as of 2026-07-08.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.