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Serving leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Express Scripts
Chinese Patent Office

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203790

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NDA 203790 describes ADAPALENE AND BENZOYL PEROXIDE, which is a drug marketed by Actavis Mid Atlantic and is included in one NDA. It is available from one supplier. 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 eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Summary for 203790
Applicant:Actavis Mid Atlantic
Ingredient:adapalene; benzoyl peroxide
Formulation / Manufacturing:see details
Pharmacology for NDA: 203790
Suppliers and Packaging for NDA: 203790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 203790 ANDA Actavis Pharma, Inc. 0472-0310 0472-0310-45 1 TUBE in 1 CARTON (0472-0310-45) > 45 g in 1 TUBE
ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 203790 ANDA Actavis Pharma, Inc. 0472-0310 0472-0310-38 1 BOTTLE, PUMP in 1 CARTON (0472-0310-38) > 45 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%;2.5%
Approval Date:Sep 30, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Jan 23, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
US Department of Justice

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