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FDA ANDA · ANDA091433

DOXERCALCIFEROL

Sponsor: HIKMA

APPLICATION
ANDA091433
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-23
LATEST ACTION
2020-10-13
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

2020-10-13Labeling · Supplement 7 · standardAP
2014-01-14OriginalAP
2011-09-23Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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