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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091314

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NDA 091314 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 091314
Tradename:ADAPALENE
Applicant:Glenmark Generics
Ingredient:adapalene
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091314
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 091314
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 N 42546-720-45
ADAPALENE adapalene GEL;TOPICAL 091314 ANDA Glenmark Pharmaceuticals Inc., USA 68462-403 N 68462-403-55

Profile for product number 001

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

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