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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 091314

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NDA 091314 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, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms, and is included in twenty NDAs. It is available from thirty-six 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. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Summary for 091314

Tradename:	ADAPALENE
Applicant:	Glenmark Pharms Inc
Ingredient:	adapalene
Patents:	0

Pharmacology for NDA: 091314

Medical Subject Heading (MeSH) Categories for 091314

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Suppliers and Packaging for NDA: 091314

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADAPALENE	adapalene	GEL;TOPICAL	091314	ANDA	Safeway, Inc.	21130-708	21130-708-05	1 TUBE in 1 CARTON (21130-708-05) / 15 g in 1 TUBE
ADAPALENE	adapalene	GEL;TOPICAL	091314	ANDA	TOP CARE (Topco Associates LLC)	36800-088	36800-088-05	1 TUBE in 1 CARTON (36800-088-05) / 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	GEL;TOPICAL			Strength	0.1%
Approval Date:	Jul 1, 2010	TE:		RLD:	No

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