Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206164
Company: ENCUBE

Products on ANDA 206164

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.1%;2.5%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206164

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206164

ADAPALENE AND BENZOYL PEROXIDE

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	TARO
EPIDUO	ADAPALENE; BENZOYL PEROXIDE	0.1%;2.5%	GEL;TOPICAL	Prescription	Yes	AB	022320	GALDERMA LABS LP