APPLICATION
ANDA040528
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-13
LATEST ACTION
2025-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MERCAPTOPURINEPrescription
MERCAPTOPURINE 50MG · TABLET · ORAL
Approval history
2025-06-26Labeling · Supplement 13 · standardAP
2021-11-22Labeling · Supplement 12 · standardAP
2021-01-25Labeling · Supplement 10 · standardAP
2021-01-25Labeling · Supplement 11 · standardAP
2012-08-01Labeling · Supplement 4AP
2007-11-26Labeling · Supplement 2AP
2004-02-13OriginalAP
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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