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ANDA Review Documents – Paclitaxel Protein-bound Particles (ANDA 212700, Feb 03, 2022–Oct 08, 2024)
ANDA Review Documents – Paclitaxel Protein-bound Particles (ANDA 212700, Feb 03, 2022–Oct 08, 2024)
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Request Contents: Complete ANDA review documents for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial
ANDA number: 212700
Submission date: February 03, 2022
Approval date: October 08, 2024
CMC and BE review documents
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- 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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