APPLICATION
ANDA204467
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-28
LATEST ACTION
2025-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALLOPURINOLPrescription
ALLOPURINOL 300MG · TABLET · ORAL
ALLOPURINOLPrescription
ALLOPURINOL 200MG · TABLET · ORAL
ALLOPURINOLPrescription
ALLOPURINOL 100MG · TABLET · ORAL
Approval history
2025-10-16Labeling · Supplement 18 · standardAP
2024-02-05Labeling · Supplement 12 · standardAP
2024-02-05Labeling · Supplement 5 · standardAP
2023-03-15Manufacturing (CMC) · Supplement 7 · unknownAP
2016-07-28UNKNOWN · OriginalAP
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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