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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office

Generated: March 22, 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, Perrigo Israel, and Taro, and is included in three NDAs. It is available from three 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. Six 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 N 0472-0310-45
ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 203790 ANDA Actavis Pharma, Inc. 0472-0310 N 0472-0310-38

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 hundreds of leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Johnson and Johnson
Farmers Insurance

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