Labels – Reference Product ANDA 076512 (Cytarabine 100 mg/mL) Evaluation

Labels – Reference Product ANDA 076512 (Cytarabine 100 mg/mL) Evaluation

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Request Contents: Container, carton, and package insert labels for Reference Product ANDA 076512 (Cytarabine 100 mg/mL) for evaluation of ANDA-approved labeling changes.
  • 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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