APPLICATION
NDA013378
TYPE
NDA
ORIGINAL APPROVAL
1964-12-23
LATEST ACTION
1998-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DYMELORDiscontinued
ACETOHEXAMIDE 500MG · TABLET · ORAL
DYMELORDiscontinued
ACETOHEXAMIDE 250MG · TABLET · ORAL
Approval history
1998-10-19Manufacturing (CMC) · Supplement 32 · priorityAP
1998-06-16Manufacturing (CMC) · Supplement 31 · priorityAP
1990-11-27Labeling · Supplement 30AP
1988-12-29Labeling · Supplement 29AP
1987-01-30Labeling · Supplement 28AP
1986-09-15Manufacturing (CMC) · Supplement 27 · priorityAP
1986-05-02Labeling · Supplement 26AP
1986-03-18Manufacturing (CMC) · Supplement 25 · priorityAP
1985-02-14Labeling · Supplement 24AP
1983-01-31Manufacturing (CMC) · Supplement 22 · priorityAP
1981-02-23Labeling · Supplement 18AP
1980-10-14Manufacturing (CMC) · Supplement 19 · priorityAP
1980-03-21Manufacturing (CMC) · Supplement 17 · priorityAP
1979-11-27Manufacturing (CMC) · Supplement 16 · priorityAP
1979-01-09Labeling · Supplement 15AP
1976-09-15Manufacturing (CMC) · Supplement 14 · priorityAP
1976-07-21Manufacturing (CMC) · Supplement 13 · priorityAP
1964-12-23Type 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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