APPLICATION
ANDA088483
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-08
LATEST ACTION
2014-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ANTABUSE · ReferenceDiscontinued
DISULFIRAM 500MG · TABLET · ORAL
Approval history
2014-01-13Manufacturing (CMC) · Supplement 27 · unknownAP
2003-11-18Labeling · Supplement 14AP
2001-06-14Manufacturing (CMC) · Supplement 12AP
2000-07-07Manufacturing (CMC) · Supplement 11AP
1997-04-07Labeling · Supplement 10AP
1994-12-20Manufacturing (CMC) · Supplement 9AP
1994-05-11Manufacturing (CMC) · Supplement 8AP
1993-02-22Labeling · Supplement 7AP
1986-07-14Manufacturing (CMC) · Supplement 3AP
1985-07-08Manufacturing (CMC) · Supplement 2AP
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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