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approval · primary record

DABIGATRAN ETEXILATE MESYLATE

FDA · NDA · 2025-06-17

AgencyFDA
Submission typeNDA
Action date2025-06-17
BrandPRADAXA
SponsorBOEHRINGER INGELHEIM
RouteORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:35:42.163Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:DABIGATRAN ETEXILATE MESYLATE:2025-06-17

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DABIGATRAN ETEXILATE MESYLATE — approval | AEaH