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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022320
Company: GALDERMA LABS LP

Summary Review

Products on NDA 022320

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022320

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.html 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

Labels for NDA 022320

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

Therapeutic Equivalents for NDA 022320

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	206164	ENCUBE
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	PADAGIS ISRAEL
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.1%;2.5%	GEL;TOPICAL	Prescription	No	AB	206959	SUN PHARMA CANADA
EPIDUO	ADAPALENE; BENZOYL PEROXIDE	0.1%;2.5%	GEL;TOPICAL	Prescription	Yes	AB	022320	GALDERMA LABS LP

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