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Generated: May 25, 2018

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, Call Inc, and Perrigo Israel, and is included in eleven 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. Six suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Summary for 090962
Tradename:ADAPALENE
Applicant:Pliva Hrvatska Doo
Ingredient:adapalene
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090962
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 090962
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 N 0093-6301-95
ADAPALENE adapalene GEL;TOPICAL 090962 ANDA Physicians Total Care, Inc. 54868-6132 E 54868-6132-0

Profile for product number 001

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

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