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approval · primary record

DOLUTEGRAVIR

FDA · NDA · 2026-05-07

AgencyFDA
Submission typeNDA
Action date2026-05-07
BrandDOLUTEGRAVIR, LAMIVUDINE and TENOFOVIR DISOPROXIL FUMARATE
SponsorASPEN SA OPERATIONS (PTY) LTD
RouteORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T02:34:19.337Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:DOLUTEGRAVIR:2026-05-07

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DOLUTEGRAVIR — approval | AEaH