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

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

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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