APPLICATION
ANDA088228
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-01
LATEST ACTION
1998-05-06
ROUTE
TOPICAL
DOSAGE FORM
LOTION/SHAMPOO
MARKETING STATUS
Discontinued
Products
SELENIUM SULFIDEDiscontinued
SELENIUM SULFIDE 2.5% · LOTION/SHAMPOO · TOPICAL
Approval history
1998-05-06Manufacturing (CMC) · Supplement 11AP
1998-05-06Manufacturing (CMC) · Supplement 12AP
1990-11-15Labeling · Supplement 10AP
1987-05-18Manufacturing (CMC) · Supplement 6AP
1987-05-18Manufacturing (CMC) · Supplement 7AP
1986-12-24Manufacturing (CMC) · Supplement 4AP
1983-09-01OriginalAP
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.