APPLICATION
NDA007883
TYPE
NDA
ORIGINAL APPROVAL
1951-08-28
LATEST ACTION
2000-08-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ANTABUSE · ReferenceDiscontinued
DISULFIRAM 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ANTABUSE · ReferenceDiscontinued
DISULFIRAM 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-08-29Labeling · Supplement 30 · standardAP
1995-02-21Labeling · Supplement 29AP
1989-03-27Manufacturing (CMC) · Supplement 28 · priorityAP
1987-08-14Manufacturing (CMC) · Supplement 26 · priorityAP
1986-07-28Labeling · Supplement 24AP
1985-05-20Manufacturing (CMC) · Supplement 23 · priorityAP
1985-04-01Manufacturing (CMC) · Supplement 20 · priorityAP
1984-10-15Manufacturing (CMC) · Supplement 22 · priorityAP
1982-07-26Manufacturing (CMC) · Supplement 19 · priorityAP
1982-07-20Manufacturing (CMC) · Supplement 15 · priorityAP
1982-02-11Manufacturing (CMC) · Supplement 16 · priorityAP
1980-03-20Labeling · Supplement 13AP
1980-03-20Labeling · Supplement 14AP
1980-02-21Manufacturing (CMC) · Supplement 10 · priorityAP
1979-05-25Manufacturing (CMC) · Supplement 12 · priorityAP
1978-12-22Labeling · Supplement 9AP
1978-09-26Labeling · Supplement 11AP
1977-01-05Labeling · Supplement 8AP
1951-08-28Type 1 - New Molecular Entity · Original · priorityAP
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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