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Serving leading biopharmaceutical companies globally:

Queensland Health
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Colorcon
Express Scripts
Chubb
Cipla
Chinese Patent Office
Fuji
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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
Tradename:ADAPALENE AND BENZOYL PEROXIDE
Applicant:Actavis Mid Atlantic
Ingredient:adapalene; benzoyl peroxide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203790
Ingredient-typeRetinoids
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:

Baxter
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Julphar
Boehringer Ingelheim
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Healthtrust
US Department of Justice
Citi
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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