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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201000

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NDA 201000 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 twelve 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. Seven suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Summary for 201000
Tradename:ADAPALENE
Applicant:Actavis Mid Atlantic
Ingredient:adapalene
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201000
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 201000
Suppliers and Packaging for NDA: 201000
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE adapalene GEL;TOPICAL 201000 ANDA Actavis Pharma, Inc. 0472-0126 N 0472-0126-45

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%
Approval Date:Oct 27, 2014TE:ABRLD:No

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Citi
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