Last Updated: June 17, 2026

Details for New Drug Application (NDA): 208322

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NDA 208322 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms, P And L, Sun Pharma Canada, Waylis Therap, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms, and is included in twenty NDAs. It is available from thirty-four suppliers. Additional details are available on the ADAPALENE profile page.

The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Summary for 208322

Tradename:	ADAPALENE
Applicant:	Sun Pharma Canada
Ingredient:	adapalene
Patents:	0

Pharmacology for NDA: 208322

Medical Subject Heading (MeSH) Categories for 208322

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Suppliers and Packaging for NDA: 208322

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADAPALENE	adapalene	GEL;TOPICAL	208322	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1377	51672-1377-6	1 TUBE in 1 CARTON (51672-1377-6) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.3%
Approval Date:	Jun 23, 2016	TE:	AB	RLD:	No

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