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approval · primary record

BREXANOLONE

FDA · NDA · 2025-01-23

AgencyFDA
Submission typeNDA
Action date2025-01-23
BrandZULRESSO
SponsorSAGE THERAP SUPERNUS
RouteINTRAVENOUS

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T10:38:34.851Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:BREXANOLONE:2025-01-23

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Same entity, elsewhere in the suite