APPLICATION
ANDA210756
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-09
LATEST ACTION
2025-04-02
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DECITABINEDiscontinued
DECITABINE 50MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2025-04-02Labeling · Supplement 2 · standardAP
2025-04-02Labeling · Supplement 3 · standardAP
2025-04-02Labeling · Supplement 1 · standardAP
2018-11-09UNKNOWN · 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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