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Labels – NDA 017422 BICNU (Carmustine 100mg/vial, All Levels for RLD Comparison)
Labels – NDA 017422 BICNU (Carmustine 100mg/vial, All Levels for RLD Comparison)
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Request Contents: Most recent labels for NDA 017422, BICNU (Carmustine, 100mg/vial), including all levels of labeling for RLD comparison with approved generic ANDA.
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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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