Amneal adds metformin labeling approval alongside bosentan updates
FDA approved a new labeling supplement for Amneal's generic metformin hydrochloride tablets, joining two earlier bosentan labeling approvals.
Amneal Pharmaceuticals saw a third labeling supplement approved this week, this time for its generic metformin hydrochloride tablets, alongside the previously reported bosentan updates.
- Supplement 29, a labeling submission for metformin hydrochloride tablets in 1GM, 500MG, and 850MG strengths under ANDA077880, was approved with a status date of 2026-07-23.1
- Supplement 15, a labeling submission for bosentan tablets in 125MG and 62.5MG strengths under ANDA209742, was approved with a status date of 2026-07-23.2
- Supplement 13, also a labeling submission for the same bosentan tablet strengths, was approved with the same status date of 2026-07-23.3
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