APPLICATION
ANDA203929
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-07
LATEST ACTION
2025-03-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOXERCALCIFEROLDiscontinued
DOXERCALCIFEROL 2MCG/ML (2MCG/ML) · INJECTABLE · INJECTION
DOXERCALCIFEROLDiscontinued
DOXERCALCIFEROL 4MCG/2ML (2MCG/ML) · INJECTABLE · INJECTION
Approval history
2025-03-14Labeling · Supplement 8 · standardAP
2016-10-13Labeling · Supplement 4 · standardAP
2015-05-07UNKNOWN · OriginalAP
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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