APPLICATION
ANDA209540
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-04
LATEST ACTION
2020-11-05
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
AZACITIDINEPrescription
AZACITIDINE 100MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS
Approval history
2020-11-05Labeling · Supplement 2 · standardAP
2019-04-26Labeling · Supplement 1 · standardAP
2018-05-04UNKNOWN · 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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