APPLICATION
ANDA206033
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-22
LATEST ACTION
2020-11-04
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DECITABINEPrescription
DECITABINE 50MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2020-11-04Labeling · Supplement 3 · standardAP
2020-11-04Labeling · Supplement 2 · standardAP
2017-09-22UNKNOWN · 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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