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Serving 500+ biopharmaceutical companies globally:

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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091314

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NDA 091314 describes ADAPALENE, which is a drug marketed by Actavis Mid Atlantic, Glenmark Generics, Taro, Fougera Pharms, Pliva Hrvatska Doo, Call Inc, and Tolmar, 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 NDA: 091314

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

Pharmacology for NDA: 091314

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 091314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE
adapalene
GEL;TOPICAL 091314 ANDA PruGen, Inc. 42546-720 42546-720-45 1 TUBE in 1 CARTON (42546-720-45) > 45 g in 1 TUBE
ADAPALENE
adapalene
GEL;TOPICAL 091314 ANDA Glenmark Pharmaceuticals Inc., USA 68462-403 68462-403-55 45 g in 1 TUBE (68462-403-55)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
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Harvard Business School
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Chubb

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