APPLICATION
ANDA088821
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-09
LATEST ACTION
2001-08-30
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
VAGILIADiscontinued
TRIPLE SULFA (SULFABENZAMIDE 3.7%, SULFACETAMIDE 2.86%, SULFATHIAZOLE) 3.42% · CREAM · VAGINAL
Approval history
2001-08-30Manufacturing (CMC) · Supplement 4AP
1990-02-16Manufacturing (CMC) · Supplement 2AP
1988-05-09Labeling · Supplement 1AP
1987-11-09OriginalAP
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.