APPLICATION
ANDA071587
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-02
LATEST ACTION
2026-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LOPURINPrescription
ALLOPURINOL 300MG · TABLET · ORAL
Approval history
2026-07-21Labeling · Supplement 16 · standardAP
1997-07-08Manufacturing (CMC) · Supplement 10AP
1993-10-18Manufacturing (CMC) · Supplement 9AP
1988-06-14Labeling · Supplement 8AP
1988-04-22Labeling · Supplement 6AP
1988-04-22Manufacturing (CMC) · Supplement 4AP
1988-04-22Manufacturing (CMC) · Supplement 5AP
1988-04-22Manufacturing (CMC) · Supplement 3AP
1988-02-23Labeling · Supplement 7AP
1987-07-16Manufacturing (CMC) · Supplement 1AP
1987-04-02OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.