APPLICATION
ANDA204949
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-28
LATEST ACTION
2026-06-09
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued
Products
AZACITIDINEDiscontinued
AZACITIDINE 100MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS
Approval history
2026-06-09Labeling · Supplement 6 · standardAP
2026-06-09Labeling · Supplement 4 · standardAP
2026-06-09Labeling · Supplement 7 · standardAP
2019-02-12Labeling · Supplement 2 · standardAP
2019-02-12Labeling · Supplement 3 · standardAP
2016-04-28UNKNOWN · Original · standardAP
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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