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Serving leading biopharmaceutical companies globally:

US Army
Cerilliant
Colorcon
Accenture
Chubb
Johnson and Johnson
US Department of Justice
Farmers Insurance
Daiichi Sankyo
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208322

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NDA 208322 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Glenmark Generics, Pliva Hrvatska Doo, Taro, Tolmar, and Call Inc, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the ADAPALENE profile page.

The generic ingredient in ADAPALENE is adapalene; benzoyl peroxide. There are twelve 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 208322
Tradename:ADAPALENE
Applicant:Taro
Ingredient:adapalene
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 208322
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 208322
Suppliers and Packaging for NDA: 208322
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE adapalene GEL;TOPICAL 208322 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1377 51672-1377-6 1 TUBE in 1 CARTON (51672-1377-6) > 45 g in 1 TUBE
ADAPALENE adapalene GEL;TOPICAL 208322 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1377 51672-1377-9 1 BOTTLE, PUMP in 1 CARTON (51672-1377-9) > 45 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%
Approval Date:Jun 23, 2016TE:ABRLD:No

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Healthtrust
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Federal Trade Commission
Fish and Richardson
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Julphar
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