APPLICATION
ANDA086890
TYPE
ANDA
ORIGINAL APPROVAL
1981-03-31
LATEST ACTION
1998-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DISULFIRAMDiscontinued
DISULFIRAM 500MG · TABLET · ORAL
Approval history
1998-04-14Labeling · Supplement 22AP
1992-05-13Manufacturing (CMC) · Supplement 21AP
1991-05-31Manufacturing (CMC) · Supplement 18AP
1991-01-28Manufacturing (CMC) · Supplement 19AP
1990-06-29Manufacturing (CMC) · Supplement 17AP
1988-10-14Manufacturing (CMC) · Supplement 15AP
1988-10-14Manufacturing (CMC) · Supplement 14AP
1985-08-29Manufacturing (CMC) · Supplement 11AP
1985-08-29Manufacturing (CMC) · Supplement 12AP
1985-08-29Manufacturing (CMC) · Supplement 10AP
1982-05-26Manufacturing (CMC) · Supplement 8AP
1981-03-31OriginalAP
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.