FDA ANDA 217250, ERIBULIN MESYLATE, BAXTER HLTHCARE CORP, 10/01/2024

Contents: Summary Basis of Approval of CMC (Chemistry, Manufacture and Control) section of Drug Substance for the Eribulin Mesylate Injection, 1mg/2mL (0.5mg/mL) application #A217250, approved on October 1, 2024.

ANDA: 217250
Company: BAXTER HLTHCARE CORP
Drug Name: ERIBULIN MESYLATE
Active Ingredients: ERIBULIN MESYLATE
Strength: 1MG/2ML (0.5MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 10/01/2024
Marketing Status: Prescription
Submission Classification: ORIG-1

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