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Serving leading biopharmaceutical companies globally:

US Department of Justice
Federal Trade Commission
Deloitte
UBS
Merck
Fish and Richardson
Argus Health
Johnson and Johnson
Moodys
Cerilliant

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090962

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NDA 090962 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 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 090962

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090962

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 090962

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE adapalene GEL;TOPICAL 090962 ANDA Teva Pharmaceuticals USA, Inc. 0093-6301 0093-6301-95 45 g in 1 TUBE (0093-6301-95)
ADAPALENE adapalene GEL;TOPICAL 090962 ANDA Physicians Total Care, Inc. 54868-6132 54868-6132-0 45 g in 1 TUBE (54868-6132-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%
Approval Date:Jun 2, 2010TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Dow
Healthtrust
McKinsey
Fish and Richardson
Moodys
Accenture
Julphar
QuintilesIMS
Harvard Business School

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