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approval · primary record

NALTREXONE

FDA · NDA · 2025-12-22

AgencyFDA
Submission typeNDA
Action date2025-12-22
BrandVIVITROL
SponsorALKERMES
RouteINTRAMUSCULAR

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:34:12.558Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:NALTREXONE:2025-12-22

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NALTREXONE — approval | AEaH