APPLICATION
ANDA087285
TYPE
ANDA
ORIGINAL APPROVAL
1982-11-15
LATEST ACTION
1997-09-16
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
TRIPLE SULFADiscontinued
TRIPLE SULFA (SULFABENZAMIDE 3.7%, SULFACETAMIDE 2.86%, SULFATHIAZOLE) 3.42% · CREAM · VAGINAL
Approval history
1997-09-16Manufacturing (CMC) · Supplement 14AP
1996-04-29Manufacturing (CMC) · Supplement 13AP
1995-10-18Manufacturing (CMC) · Supplement 11AP
1995-08-07Manufacturing (CMC) · Supplement 12AP
1995-08-07Manufacturing (CMC) · Supplement 9AP
1992-12-04Labeling · Supplement 10AP
1987-10-28Manufacturing (CMC) · Supplement 6AP
1982-11-15OriginalAP
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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