Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#GLIMEPIRIDE ×
Actualizaciones regulatorias
27 sept 2026•1 min de lectura
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.
1
Actualizaciones regulatorias
5 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
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.