APPLICATION
ANDA207234
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-23
LATEST ACTION
2025-07-01
ROUTE
SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
AZACITIDINEPrescription
AZACITIDINE 100MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS
Approval history
2025-07-01Labeling · Supplement 4 · standardAP
2025-07-01Labeling · Supplement 5 · standardAP
2020-09-21Labeling · Supplement 2 · standardAP
2020-09-21Labeling · Supplement 3 · standardAP
2017-06-23UNKNOWN · 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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