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approval · primary record

AMITRIPTYLINE HYDROCHLORIDE

FDA · NDA · 2025-06-24

AgencyFDA
Submission typeNDA
Action date2025-06-24
BrandLIMBITROL
SponsorCHARTWELL RX
RouteORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:34:54.314Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:AMITRIPTYLINE HYDROCHLORIDE:2025-06-24

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AMITRIPTYLINE HYDROCHLORIDE — approval | AEaH