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approval · primary record

AMANTADINE HYDROCHLORIDE

FDA · NDA · 2025-07-10

AgencyFDA
Submission typeNDA
Action date2025-07-10
BrandOSMOLEX ER
SponsorSUPERNUS PHARMS
RouteORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:35:37.385Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:AMANTADINE HYDROCHLORIDE:2025-07-10

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AMANTADINE HYDROCHLORIDE — approval | AEaH