Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050741
Company: STIEFEL
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 Yes
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
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

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 090979 PERRIGO ISRAEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;1.2% GEL;TOPICAL Prescription No AB 206218 TARO PHARMS
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE 5%;1.2% GEL;TOPICAL Prescription No AB 203688 TOLMAR
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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