FDA ANDA · ANDA091433
DOXERCALCIFEROL
Sponsor: HIKMA
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APPLICATION
ANDA091433
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-23
LATEST ACTION
2026-10-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DOXERCALCIFEROLDiscontinued
DOXERCALCIFEROL 2.5MCG · CAPSULE · ORAL
DOXERCALCIFEROLDiscontinued
DOXERCALCIFEROL 0.5MCG · CAPSULE · ORAL
DOXERCALCIFEROLDiscontinued
DOXERCALCIFEROL 1MCG · CAPSULE · ORAL
Approval history
2026-10-02Labeling · Supplement 10 · standardAP
2020-10-13Labeling · Supplement 7 · standardAP
2014-01-14OriginalAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →