Last Updated: November 10, 2026

Details for New Drug Application (NDA): 219565

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NDA 219565 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms, P And L, Rising, Sun Pharma Canada, Waylis Therap, Actavis Labs Ut Inc, Aurobindo Pharma Ltd, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms, and is included in twenty-two NDAs. It is available from thirty-three suppliers. Additional details are available on the ADAPALENE profile page.

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

Summary for 219565

Tradename:	ADAPALENE
Applicant:	Rising
Ingredient:	adapalene
Patents:	0

Medical Subject Heading (MeSH) Categories for 219565

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	GEL;TOPICAL			Strength	0.1%
Approval Date:	Jun 30, 2026	TE:		RLD:	No

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