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FDA NDA · NDA008173

BENOQUIN

Sponsor: VALEANT PHARM INTL

APPLICATION
NDA008173
TYPE
NDA
ORIGINAL APPROVAL
1952-11-10
LATEST ACTION
2003-03-26
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

BENOQUINDiscontinued
MONOBENZONE 20% · CREAM · TOPICAL

Approval history

2003-03-26Labeling · Supplement 15 · standard — Label ↗AP
1998-03-16Manufacturing (CMC) · Supplement 14 · priorityAP
1997-11-07Manufacturing (CMC) · Supplement 13 · priorityAP
1997-09-23Manufacturing (CMC) · Supplement 12 · priorityAP
1997-04-03Manufacturing (CMC) · Supplement 11 · priorityAP
1997-01-31Manufacturing (CMC) · Supplement 10 · priorityAP
1995-01-17Labeling · Supplement 9 · standardAP
1993-04-27Manufacturing (CMC) · Supplement 7 · priorityAP
1993-04-27Manufacturing (CMC) · Supplement 8 · priorityAP
1984-08-08Labeling · Supplement 6AP
1952-11-10Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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