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approval · primary record

GEMCITABINE HYDROCHLORIDE

FDA · NDA · 2025-06-27

AgencyFDA
Submission typeNDA
Action date2025-06-27
BrandAVGEMSI
SponsorAVYXA HOLDINGS
RouteINTRAVENOUS

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-28T03:30:37.201Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: FDA:GEMCITABINE HYDROCHLORIDE:2025-06-27

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GEMCITABINE HYDROCHLORIDE — approval | AEaH