規制動向
2026年9月3日•1分で読めます
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.
規制動向
2026年8月30日•1分で読めます
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.