APPLICATION
ANDA018659
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-24
LATEST ACTION
2024-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALLOPURINOLPrescription
ALLOPURINOL 100MG · TABLET · ORAL
ALLOPURINOLPrescription
ALLOPURINOL 300MG · TABLET · ORAL
Approval history
2024-03-12Labeling · Supplement 33 · standardAP
2023-09-18Labeling · Supplement 30 · standardAP
2019-04-23Labeling · Supplement 24 · standardAP
2003-07-31Labeling · Supplement 14AP
2002-11-13Manufacturing (CMC) · Supplement 12AP
1998-02-25Manufacturing (CMC) · Supplement 11AP
1998-02-05Manufacturing (CMC) · Supplement 10AP
1993-11-23Manufacturing (CMC) · Supplement 9AP
1991-10-18Manufacturing (CMC) · Supplement 4AP
1990-08-07Manufacturing (CMC) · Supplement 3AP
1990-08-07Labeling · Supplement 2AP
1990-01-31Manufacturing (CMC) · Supplement 7AP
1988-01-22Manufacturing (CMC) · Supplement 5AP
1988-01-22Manufacturing (CMC) · Supplement 6AP
1987-01-16Manufacturing (CMC) · Supplement 1AP
1986-10-24OriginalAP
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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