Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209148
Company: SUN PHARMA CANADA

Products on ANDA 209148

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209148

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209148Orig1s000Ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/11/2024	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 209148

ADAPALENE AND BENZOYL PEROXIDE

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	SUN PHARMA CANADA
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