APPLICATION
NDA013026
TYPE
NDA
ORIGINAL APPROVAL
1965-04-30
LATEST ACTION
2023-08-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRECATOR · ReferenceDiscontinued
ETHIONAMIDE 250MG · TABLET · ORAL
Approval history
2014-04-29Manufacturing (CMC) · Supplement 28 · priorityAP
2001-10-03Manufacturing (CMC) · Supplement 21 · priorityAP
2001-07-31Manufacturing (CMC) · Supplement 20 · priorityAP
1998-11-12Manufacturing (CMC) · Supplement 19 · priorityAP
1998-10-05Manufacturing (CMC) · Supplement 18 · priorityAP
1998-04-23Manufacturing (CMC) · Supplement 17 · priorityAP
1997-03-10Labeling · Supplement 9AP
1994-05-17Manufacturing (CMC) · Supplement 16 · priorityAP
1994-03-18Manufacturing (CMC) · Supplement 15 · priorityAP
1992-12-29Manufacturing (CMC) · Supplement 13 · priorityAP
1991-04-26Manufacturing (CMC) · Supplement 12 · priorityAP
1990-05-11Manufacturing (CMC) · Supplement 11 · priorityAP
1989-06-21Manufacturing (CMC) · Supplement 10 · priorityAP
1988-05-31Manufacturing (CMC) · Supplement 8 · priorityAP
1987-06-04Manufacturing (CMC) · Supplement 7 · priorityAP
1987-03-03Manufacturing (CMC) · Supplement 6 · priorityAP
1984-10-26Manufacturing (CMC) · Supplement 5 · priorityAP
1981-04-01Manufacturing (CMC) · Supplement 4 · priorityAP
1974-06-20Supplement · Supplement 3 · priorityAP
1965-04-30Type 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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