FDA ANDA 218281, ERIBULIN MESYLATE, JIANGXI QINGFENG, 06/28/2024

Contents: Approval Letter and the Summary Basis of Approval of CMC (Chemistry, Manufacture and Control) section for ERIBULIN MESYLATE 1MG/2ML (0.5mg/mL) ANDAs A218281 and A214850 approved on Jun 18, 2024 and July 18, 2024 respectively

ANDA: 218281
Company: JIANGXI QINGFENG
Drug Name: ERIBULIN MESYLATE
Active Ingredients: ERIBULIN MESYLATE
Strength: 1MG/2ML (0.5MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 06/28/2024
Marketing Status: Prescription
Submission Classification: ORIG-1

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