APPLICATION
ANDA086889
TYPE
ANDA
ORIGINAL APPROVAL
1981-03-31
LATEST ACTION
1998-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DISULFIRAMDiscontinued
DISULFIRAM 250MG · TABLET · ORAL
Approval history
1998-04-14Labeling · Supplement 21AP
1992-05-13Manufacturing (CMC) · Supplement 20AP
1991-05-31Manufacturing (CMC) · Supplement 17AP
1991-01-28Manufacturing (CMC) · Supplement 18AP
1990-06-29Manufacturing (CMC) · Supplement 16AP
1990-02-27Manufacturing (CMC) · Supplement 19AP
1989-04-03Manufacturing (CMC) · Supplement 13AP
1989-04-03Manufacturing (CMC) · Supplement 14AP
1985-04-12Manufacturing (CMC) · Supplement 10AP
1985-04-12Manufacturing (CMC) · Supplement 11AP
1982-05-26Manufacturing (CMC) · Supplement 7AP
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.
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