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Aug 5, 2026Regulatory decision

Mylan gets ANDA labeling supplement approved for fenofibrate tablets

FDA approved a labeling supplement for Mylan's generic fenofibrate tablets on August 5, 2026.

Mylan Pharms Inc had one regulatory item this week, a labeling change to its already-approved generic fenofibrate.

  • The FDA approved supplement number 9 for Mylan's fenofibrate tablets under ANDA204475, a labeling submission with standard review priority, with a status date of 2026-08-05.1 The product covers oral fenofibrate tablets in 40 mg and 120 mg strengths.1

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