APPLICATION
NDA020532
TYPE
NDA
ORIGINAL APPROVAL
1996-08-26
LATEST ACTION
2001-05-16
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Over-the-counter
Products
IVY BLOCK · ReferenceOver-the-counter
BENTOQUATAM 5% · LOTION · TOPICAL
Approval history
2001-05-16Labeling · Supplement 8 · standardAP
2000-08-02Manufacturing (CMC) · Supplement 9 · priorityAP
1998-12-09Manufacturing (CMC) · Supplement 6 · priorityAP
1998-04-13Manufacturing (CMC) · Supplement 4 · priorityAP
1998-03-25Manufacturing (CMC) · Supplement 3 · priorityAP
1998-03-03Manufacturing (CMC) · Supplement 5 · priorityAP
1997-10-16Manufacturing (CMC) · Supplement 2 · priorityAP
1996-10-04Manufacturing (CMC) · Supplement 1 · 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.
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.