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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050741
Company: STIEFEL

Products on NDA 050741

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUAC	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050741

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2002	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50741lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50741ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/050741_duac.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/2015	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050741s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050741Orig1s024ltr.pdf
10/15/2014	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
05/19/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/27/2013	SUPPL-21	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050741s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050741Orig1s021ltr.pdf
06/07/2013	SUPPL-20	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050741Orig1s020ltr.pdf
12/21/2011	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050741s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050741s019ltr.pdf
11/14/2012	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/08/2010	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050741s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050741s015ltr.pdf
07/22/2008	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050741s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050741s011ltr.pdf
11/17/2003	SUPPL-4	Manufacturing (CMC)-Control	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741scs004_duac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741scs004ltr.pdf
10/20/2003	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741slr003_duac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50741slr003ltr.pdf

Labels for NDA 050741

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/15/2015	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050741s024lbl.pdf
12/27/2013	SUPPL-21	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050741s021lbl.pdf
12/27/2013	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050741s021lbl.pdf
12/21/2011	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050741s019lbl.pdf
11/08/2010	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050741s015lbl.pdf
07/22/2008	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050741s011lbl.pdf
11/17/2003	SUPPL-4	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741scs004_duac_lbl.pdf
10/20/2003	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50741slr003_duac_lbl.pdf
08/26/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50741lbl.pdf

Therapeutic Equivalents for NDA 050741

DUAC

GEL;TOPICAL; 5%;1.2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	212433	ENCUBE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	090979	PADAGIS ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	206218	TARO
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	No	AB	210794	ZYDUS PHARMS
DUAC	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;1.2%	GEL;TOPICAL	Prescription	Yes	AB	050741	STIEFEL

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