APPLICATION
ANDA204607
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-31
LATEST ACTION
2021-06-25
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DECITABINEPrescription
DECITABINE 50MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2021-06-25Labeling · Supplement 5 · standardAP
2020-11-10Labeling · Supplement 3 · standardAP
2017-05-31UNKNOWN · 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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