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BE Review Package – ANDA 213195 (Naltrexone ER Injectable Suspension, 380 mg/vial, Single-Dose)
BE Review Package – ANDA 213195 (Naltrexone ER Injectable Suspension, 380 mg/vial, Single-Dose)
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Request Contents: BE review package for ANDA 213195 Naltrexone for Extended-Release Injectable Suspension, 380 mg/vial, Single-Dose Vial
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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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