APPLICATION
ANDA071450
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-09
LATEST ACTION
2024-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALLOPURINOLPrescription
ALLOPURINOL 300MG · TABLET · ORAL
ALLOPURINOLPrescription
ALLOPURINOL 100MG · TABLET · ORAL
Approval history
2024-01-29Labeling · Supplement 44 · standardAP
2019-05-15Labeling · Supplement 40 · standardAP
2007-08-22Labeling · Supplement 31AP
2001-04-27Manufacturing (CMC) · Supplement 14AP
2000-05-16Manufacturing (CMC) · Supplement 12AP
2000-05-16Manufacturing (CMC) · Supplement 13AP
1997-12-05Manufacturing (CMC) · Supplement 11AP
1997-02-24Manufacturing (CMC) · Supplement 10AP
1995-06-22Manufacturing (CMC) · Supplement 9AP
1994-01-12Manufacturing (CMC) · Supplement 8AP
1991-02-04Labeling · Supplement 45AP
1991-02-04Labeling · Supplement 6AP
1990-07-09Manufacturing (CMC) · Supplement 3AP
1987-09-01Manufacturing (CMC) · Supplement 2AP
1987-01-09OriginalAP
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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