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approval · primary record

BEDAQUILINE FUMARATE

FDA · NDA · 2025-07-28

AgencyFDA
Submission typeNDA
Action date2025-07-28
BrandSIRTURO
SponsorJANSSEN THERAP
RouteORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:35:55.023Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:BEDAQUILINE FUMARATE:2025-07-28

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BEDAQUILINE FUMARATE — approval | AEaH