APPLICATION
NDA018877
TYPE
NDA
ORIGINAL APPROVAL
1984-09-28
LATEST ACTION
2024-04-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ALLOPURINOLPrescription
ALLOPURINOL 300MG · TABLET · ORAL
Approval history
2015-11-13Manufacturing (CMC) · Supplement 62AP
2009-01-23Labeling · Supplement 45AP
2003-08-26Labeling · Supplement 28AP
2002-08-14Manufacturing (CMC) · Supplement 31AP
2001-04-25Manufacturing (CMC) · Supplement 30AP
2001-02-05Manufacturing (CMC) · Supplement 29AP
1998-03-30Manufacturing (CMC) · Supplement 25AP
1998-03-30Manufacturing (CMC) · Supplement 26AP
1993-07-30Manufacturing (CMC) · Supplement 21AP
1991-05-31Manufacturing (CMC) · Supplement 19AP
1991-01-28Manufacturing (CMC) · Supplement 20AP
1990-06-29Manufacturing (CMC) · Supplement 18AP
1988-07-07Manufacturing (CMC) · Supplement 17AP
1988-07-07Manufacturing (CMC) · Supplement 16AP
1987-12-17Manufacturing (CMC) · Supplement 15AP
1987-12-17Manufacturing (CMC) · Supplement 13AP
1987-12-17Manufacturing (CMC) · Supplement 14AP
1987-03-11Manufacturing (CMC) · Supplement 11AP
1985-07-03Manufacturing (CMC) · Supplement 6AP
1985-07-03Manufacturing (CMC) · Supplement 2AP
1985-07-03Manufacturing (CMC) · Supplement 7AP
1985-05-10Manufacturing (CMC) · Supplement 4AP
1985-05-10Manufacturing (CMC) · Supplement 3AP
1984-09-28OriginalAP
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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