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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 206164


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NDA 206164 describes ADAPALENE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Labs Ut Inc, Actavis Mid Atlantic, Alembic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, and Zydus Pharms, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ADAPALENE AND BENZOYL PEROXIDE profile page.

The generic ingredient in ADAPALENE AND BENZOYL PEROXIDE 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 206164
Tradename:ADAPALENE AND BENZOYL PEROXIDE
Applicant:Encube
Ingredient:adapalene; benzoyl peroxide
Patents:0
Pharmacology for NDA: 206164
Suppliers and Packaging for NDA: 206164
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206164 ANDA Encube Ethicals Private Limited 21922-052 21922-052-50 1 BOTTLE, PUMP in 1 CARTON (21922-052-50) / 45 g in 1 BOTTLE, PUMP
ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206164 ANDA GABAR HEALTH SCIENCES CORP 82429-313 82429-313-45 1 BOTTLE, PUMP in 1 CARTON (82429-313-45) / 45 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%;2.5%
Approval Date:May 23, 2018TE:ABRLD:No

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