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Actualizaciones regulatorias

Novedades regulatorias de FDA, EMA, TGA y organismos globales

#Cardiology ×

UPDATED
Actualizaciones regulatorias
3 sept 2026•1 min de lectura
FDA Approves ANDA209953 for Ranolazine Extended‑Release Tablets
The FDA has approved ANDA209953 for generic Ranolazine extended‑release tablets (500 mg and 1 g) manufactured by Ascend Laboratories and sponsored by ALKEM LABS.
UPDATED
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
FDA Approves ANDA079029 for Amiodarone Hydrochloride Tablets by Zydus
The FDA has approved ANDA079029 for oral amiodarone hydrochloride tablets (100 mg, 200 mg, 400 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.