Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022320
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPIDUO ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% 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
12/08/2008 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022320lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022320s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320_epiduo_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022320s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/01/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/01/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/01/2013 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022320s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022320Orig1s004ltr.pdf
12/14/2011 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/22320Orig1s002.pdf
02/18/2011 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022320s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2013 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022320s004lbl.pdf
12/14/2011 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s002lbl.pdf
02/18/2011 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022320s001lbl.pdf
12/08/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022320lbl.pdf

EPIDUO

GEL;TOPICAL; 0.1%;2.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 203790 ACTAVIS MID ATLANTIC
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 208108 GLENMARK PHARMS LTD
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 205033 PERRIGO UK FINCO
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 206959 TARO
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription No AB 206164 TOLMAR
EPIDUO ADAPALENE; BENZOYL PEROXIDE 0.1%;2.5% GEL;TOPICAL Prescription Yes AB 022320 GALDERMA LABS LP

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