Regulatory Updates
Sep 27, 2026•1 min read
FDA Approves ANDA077370 for Generic Glimepiride Tablets
The FDA has approved application ANDA077370 for generic glimepiride tablets (1‑8 mg) manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.
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Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves ANDA 076802 for Glimepiride Tablets (Discontinued)
FDA approved ANDA 076802 for oral glimepiride tablets in 1 mg, 2 mg and 4 mg strengths; all listed as discontinued after multiple labeling supplements.
Regulatory Updates
Aug 30, 2026•1 min read
Mylan's GLIMEPIRIDE ANDA077486 Receives FDA Approval
The FDA approved Mylan's ANDA077486 for GLIMEPIRIDE tablets (1mg, 2mg, 4mg), though all listed products are marked as discontinued.