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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 209148


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NDA 209148 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, Sun Pharma Canada, and Zydus Pharms, and is included in ten NDAs. It is available from eleven 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 209148
Tradename:ADAPALENE AND BENZOYL PEROXIDE
Applicant:Sun Pharma Canada
Ingredient:adapalene; benzoyl peroxide
Patents:0
Pharmacology for NDA: 209148
Suppliers and Packaging for NDA: 209148
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 209148 ANDA Sun Pharmaceutical Industries, Inc. 51672-1384 51672-1384-4 1 BOTTLE, PUMP in 1 CARTON (51672-1384-4) / 60 g in 1 BOTTLE, PUMP
ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 209148 ANDA Sun Pharmaceutical Industries, Inc. 51672-1384 51672-1384-9 1 BOTTLE, PUMP in 1 CARTON (51672-1384-9) / 45 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%;2.5%
Approval Date:Oct 17, 2018TE:ABRLD:No

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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