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FDA ANDA · ANDA088482

ANTABUSE

Sponsor: ODYSSEY PHARMS

APPLICATION
ANDA088482
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-08
LATEST ACTION
2014-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ANTABUSE · ReferenceDiscontinued
DISULFIRAM 250MG · TABLET · ORAL

Approval history

2014-01-13Manufacturing (CMC) · Supplement 37 · unknownAP
2002-11-15Manufacturing (CMC) · Supplement 19AP
2002-11-15Labeling · Supplement 21AP
2002-11-15Manufacturing (CMC) · Supplement 20AP
2002-04-09Manufacturing (CMC) · Supplement 17AP
2002-04-09Labeling · Supplement 18AP
2001-09-18Labeling · Supplement 16AP
2001-06-14Manufacturing (CMC) · Supplement 14AP
2001-05-02Manufacturing (CMC) · Supplement 13AP
2001-03-26Labeling · Supplement 15AP
2000-07-07Manufacturing (CMC) · Supplement 12AP
1997-04-07Labeling · Supplement 11AP
1994-12-20Manufacturing (CMC) · Supplement 10AP
1994-05-11Manufacturing (CMC) · Supplement 9AP
1993-02-22Labeling · Supplement 8AP
1990-04-04Manufacturing (CMC) · Supplement 7AP
1986-07-14Manufacturing (CMC) · Supplement 3AP
1985-07-08Manufacturing (CMC) · Supplement 2AP
1983-12-08Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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