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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207917
Company: GALDERMA LABS

Products on NDA 207917

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPIDUO FORTE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207917

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207917Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207917Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207917Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207917Orig1s004s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207917Orig1s004s008ltr.pdf
04/27/2022	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207917Orig1s004s008Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207917Orig1s004s008ltr.pdf

Labels for NDA 207917

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207917Orig1s004s008lbl.pdf
04/27/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207917Orig1s004s008Lbl.pdf
07/15/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207917Orig1s000lbl.pdf

Therapeutic Equivalents for NDA 207917

EPIDUO FORTE

GEL;TOPICAL; 0.3%;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	0.3%;2.5%	GEL;TOPICAL	Prescription	No	AB	209641	ACTAVIS LABS UT INC
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL;TOPICAL	Prescription	No	AB	214185	ALEMBIC
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL;TOPICAL	Prescription	No	AB	212464	PADAGIS ISRAEL
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL;TOPICAL	Prescription	No	AB	209148	TARO
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL;TOPICAL	Prescription	No	AB	214553	ZYDUS PHARMS
EPIDUO FORTE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL;TOPICAL	Prescription	Yes	AB	207917	GALDERMA LABS

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