APPLICATION
ANDA202969
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-28
LATEST ACTION
2021-09-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DECITABINEPrescription
DECITABINE 50MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2021-09-29Labeling · Supplement 4 · standardAP
2021-09-29Labeling · Supplement 5 · standardAP
2021-09-29Labeling · Supplement 3 · standardAP
2017-05-05Labeling · Supplement 1 · 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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