APPLICATION
NDA005794
TYPE
NDA
ORIGINAL APPROVAL
1945-09-12
LATEST ACTION
2000-05-15
ROUTE
VAGINAL
DOSAGE FORM
CREAM, TABLET
MARKETING STATUS
Discontinued
Products
SULTRINDiscontinued
TRIPLE SULFA (SULFABENZAMIDE 3.7%, SULFACETAMIDE 2.86%, SULFATHIAZOLE) 3.42% · CREAM · VAGINAL
SULTRINDiscontinued
TRIPLE SULFA (SULFABENZAMIDE 184MG, SULFACETAMIDE 143.75MG, SULFATHIAZOLE) 172.5MG · TABLET · VAGINAL
Approval history
2000-05-15Manufacturing (CMC) · Supplement 24AP
1999-11-01Manufacturing (CMC) · Supplement 23AP
1996-09-12Manufacturing (CMC) · Supplement 22AP
1992-07-01Manufacturing (CMC) · Supplement 20AP
1992-06-25Manufacturing (CMC) · Supplement 21AP
1991-11-22Labeling · Supplement 18AP
1945-09-12OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.