APPLICATION
ANDA203131
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-11
LATEST ACTION
2020-09-10
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DECITABINEPrescription
DECITABINE 50MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2020-09-10Labeling · Supplement 9 · standardAP
2020-09-10Labeling · Supplement 8 · standardAP
2019-10-09Labeling · Supplement 6 · standardAP
2017-05-03Labeling · Supplement 4 · standardAP
2013-07-11UNKNOWN · 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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