CSPC Ouyi gets FDA labeling approvals for metformin hydrochloride tablets and ER tablets
FDA approved labeling supplements for two CSPC Ouyi metformin hydrochloride ANDAs, covering standard and extended-release tablets, with status dated August 11, 2026.
CSPC Ouyi received two FDA labeling approvals this week for its metformin hydrochloride products.
- A labeling supplement, submission number 11, for ANDA205096 covering metformin hydrochloride tablets in 850MG, 1GM, and 500MG strengths was approved1, with a standard review priority and status date of 2026-08-11.
- A labeling supplement, submission number 20, for ANDA078321 covering metformin hydrochloride extended-release tablets in 500MG and 750MG strengths was approved2, also under standard review priority with a status date of 2026-08-11.
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