APPLICATION
ANDA201537
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-16
LATEST ACTION
2020-09-22
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
AZACITIDINEPrescription
AZACITIDINE 100MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS
Approval history
2020-09-22Labeling · Supplement 14 · standardAP
2019-09-09Labeling · Supplement 8 · standardAP
2017-07-28Labeling · Supplement 6 · standardAP
2017-07-28Labeling · Supplement 4 · standardAP
2017-07-28Labeling · Supplement 2 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.