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Details for New Drug Application (NDA): 090824

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NDA 090824 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 twelve 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. Two suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Summary for NDA: 090824

Tradename:
ADAPALENE
Applicant:
Fougera Pharms
Ingredient:
adapalene
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090824

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 090824

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE
adapalene
CREAM;TOPICAL 090824 ANDA E. Fougera & Co. A division of Fougera Pharmaceuticals Inc. 0168-0424 0168-0424-46 1 TUBE in 1 CARTON (0168-0424-46) > 45 g in 1 TUBE
ADAPALENE
adapalene
CREAM;TOPICAL 090824 ANDA Physicians Total Caer, Inc. 54868-6148 54868-6148-0 1 TUBE in 1 CARTON (54868-6148-0) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:Jun 30, 2010TE:ABRLD:No


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