法规动态

FDA、EMA、TGA 及全球法规动态

#GLIMEPIRIDE ×

2026年9月27日•1 分钟阅读

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.

2026年9月5日•1 分钟阅读

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.

2026年8月30日•1 分钟阅读

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.