APPLICATION
ANDA070268
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-31
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ALLOPURINOLDiscontinued
ALLOPURINOL 100MG · TABLET · ORAL
Approval history
2001-05-09Manufacturing (CMC) · Supplement 13AP
2001-04-26Manufacturing (CMC) · Supplement 12AP
1999-03-04Manufacturing (CMC) · Supplement 11AP
1994-12-20Manufacturing (CMC) · Supplement 10AP
1990-05-11Labeling · Supplement 9AP
1989-01-04Manufacturing (CMC) · Supplement 7AP
1988-01-26Manufacturing (CMC) · Supplement 6AP
1988-01-26Manufacturing (CMC) · Supplement 5AP
1987-05-03Manufacturing (CMC) · Supplement 4AP
1987-05-03Manufacturing (CMC) · Supplement 3AP
1987-03-24Manufacturing (CMC) · Supplement 2AP
1985-12-31OriginalAP
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.