APPLICATION
ANDA207475
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-02
LATEST ACTION
2024-03-29
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
AZACITIDINEPrescription
AZACITIDINE 100MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS
Approval history
2024-03-29Labeling · Supplement 10 · standardAP
2024-03-29Labeling · Supplement 9 · standardAP
2024-03-29Labeling · Supplement 7 · standardAP
2020-12-14Labeling · Supplement 4 · standardAP
2019-07-22Labeling · Supplement 2 · standardAP
2018-07-02UNKNOWN · 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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