FDA clears four Zydus labeling supplements for generic diabetes and diuretic tablets
On August 11, 2026, the FDA approved labeling supplements for Zydus generics covering glipizide/metformin, spironolactone, glyburide/metformin, and metformin.
The FDA approved a batch of labeling-related supplements for four Zydus generic products, all dated August 11, 2026.
- Glipizide and metformin hydrochloride (ANDA078905, Supplement 9) received FDA approval for a labeling change. The approved products include tablets at 2.5MG glipizide with 500MG metformin, 5MG glipizide with 500MG metformin, and 2.5MG glipizide with 250MG metformin.1
- Spironolactone (ANDA205936, Supplement 10) received FDA approval for a labeling change. The approved products are tablets at 50MG, 100MG, and 25MG strengths.2
- Glyburide and metformin hydrochloride (ANDA206748, Supplement 4) received FDA approval for a labeling change. The approved products include tablets combining 5MG glyburide with 500MG metformin, 1.25MG glyburide with 250MG metformin, and 2.5MG glyburide with 500MG metformin.3
- Metformin hydrochloride (ANDA077064, Supplement 30) received FDA approval for a labeling change. The approved products are tablets at 850MG, 1GM, and 500MG strengths.4
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.