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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 203981

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NDA 203981 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms Inc, 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 203981

Tradename:	ADAPALENE
Applicant:	Waylis Therap
Ingredient:	adapalene
Patents:	0

Medical Subject Heading (MeSH) Categories for 203981

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	0.1%
Approval Date:	Sep 23, 2016	TE:	AB	RLD:	No

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