BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Novartis
QuintilesIMS
Fish and Richardson
Mallinckrodt
Daiichi Sankyo
Merck
Queensland Health
Citi
Chinese Patent Office
Baxter

Generated: January 19, 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, and Call Inc, 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 twelve 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 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 0472-0126-45 1 TUBE in 1 CARTON (0472-0126-45) > 45 g in 1 TUBE

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Express Scripts
Mallinckrodt
McKesson
Cipla
Daiichi Sankyo
Covington
Colorcon

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