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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 201000

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NDA 201000 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Pharms Inc, P And L, Taro, 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 201000

Tradename:	ADAPALENE
Applicant:	Actavis Mid Atlantic
Ingredient:	adapalene
Patents:	0

Pharmacology for NDA: 201000

Medical Subject Heading (MeSH) Categories for 201000

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Suppliers and Packaging for NDA: 201000

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADAPALENE	adapalene	GEL;TOPICAL	201000	ANDA	Actavis Pharma, Inc.	0472-0126	0472-0126-45	1 TUBE in 1 CARTON (0472-0126-45) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.3%
Approval Date:	Oct 27, 2014	TE:	AB	RLD:	No

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