← FDA DRUG APPROVALS

FDA NDA · NDA050741

DUAC

Sponsor: STIEFEL

APPLICATION
NDA050741
TYPE
NDA
ORIGINAL APPROVAL
2002-08-26
LATEST ACTION
2015-04-15
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

DUAC · ReferencePrescription
BENZOYL PEROXIDE 5%, CLINDAMYCIN PHOSPHATE 1.2% · GEL · TOPICAL

Approval history

2015-04-15Labeling · Supplement 24 · standard — Label ↗AP
2014-10-15Manufacturing (CMC) · Supplement 23 · standardAP
2014-05-19Manufacturing (CMC) · Supplement 22 · standardAP
2013-12-27Labeling · Supplement 21 · standard — Label ↗AP
2013-06-07Labeling · Supplement 20 · standard — Letter ↗AP
2012-11-14Manufacturing (CMC) · Supplement 18 · standardAP
2011-12-21Labeling · Supplement 19 · standard — Label ↗AP
2010-11-08Labeling · Supplement 15 · unknown — Letter ↗AP
2008-07-22Labeling · Supplement 11 · standard — Label ↗AP
2003-11-17Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2003-10-20Labeling · Supplement 3 · standard — Label ↗AP
2002-08-26Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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