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approval · primary record

IRINOTECAN HYDROCHLORIDE

FDA · NDA · 2024-12-23

AgencyFDA
Submission typeNDA
Latest action2024-12-23
Approval events1
BrandONIVYDE
SponsorIPSEN
RouteINTRAVENOUS

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
2024-12-23FDANDAONIVYDEIPSENINTRAVENOUS

Provenance

  • Source: openFDA Drugs@FDA
  • Fetched at: 2026-10-30T00:32:04.609Z
  • Licence class: public-domain
  • Verdict: primary-source
  • Entity id: approval:irinotecan-hydrochloride

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Same entity, elsewhere in the suite