Mylan wins FDA approval for labeling supplement on metformin ER tablets
Mylan Pharms Inc received FDA approval for a labeling submission covering its metformin hydrochloride extended-release tablets.
This week's filing activity covers a single labeling update for Mylan's generic metformin product.
- Mylan Pharms Inc's ANDA200690 for metformin hydrochloride extended-release tablets, in 500mg and 1GM strengths, received approval for submission 16, a labeling supplement, with a status date of 2026-08-11.1
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