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Last Updated: April 22, 2021

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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, Aleor Dermaceuticals, Glenmark Generics, P And L, Taro, Tolmar, Call Inc, Glenmark Pharms Ltd, and Perrigo Uk Finco, and is included in fifteen NDAs. It is available from sixteen 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 201000
Tradename:ADAPALENE
Applicant:Actavis Mid Atlantic
Ingredient:adapalene
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201000
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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