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approval · primary record

DRONABINOL

FDA · NDA · 2026-03-25

AgencyFDA
Submission typeNDA
Latest action2026-03-25
Approval events1
BrandMARINOL
SponsorALKEM LABS LTD
RouteORAL

Approval history

1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.

DateAgencyTypeBrandSponsorRoute
2026-03-25FDANDAMARINOLALKEM LABS LTDORAL

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-30T00:28:04.143Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: approval:dronabinol

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Same entity, elsewhere in the suite