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approval · primary record

GANAXOLONE

FDA · NDA · 2025-10-16

AgencyFDA
Submission typeNDA
Action date2025-10-16
BrandZTALMY
SponsorIMMEDICA PHARMA
RouteORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T03:30:03.186Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:GANAXOLONE:2025-10-16

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GANAXOLONE — approval | AEaH