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approval · primary record

DEXMETHYLPHENIDATE HYDROCHLORIDE

FDA · NDA · 2025-09-23

AgencyFDA
Submission typeNDA
Action date2025-09-23
BrandFOCALIN XR
SponsorSANDOZ
RouteORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:34:57.128Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:DEXMETHYLPHENIDATE HYDROCHLORIDE:2025-09-23

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DEXMETHYLPHENIDATE HYDROCHLORIDE — approval | AEaH