FDA Summary Basis of Approval – CMC Section for Eribulin Mesylate Injection 1 mg/2 mL (Application A217250, Approved October 1, 2024)

FDA Summary Basis of Approval – CMC Section for Eribulin Mesylate Injection 1 mg/2 mL (Application A217250, Approved October 1, 2024)

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Original Request Contents: Summary Basis of Approval – CMC section for Drug Substance of Eribulin Mesylate Injection 1 mg/2 mL (0.5 mg/mL), Application A217250, approved October 1, 2024
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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