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Last Updated: March 5, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204593

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NDA 204593 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 204593
Tradename:ADAPALENE
Applicant:Call Inc
Ingredient:adapalene
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204593
Medical Subject Heading (MeSH) Categories for 204593
Suppliers and Packaging for NDA: 204593
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE adapalene SOLUTION;TOPICAL 204593 ANDA CALL INC. (dba Rochester Pharmaceuticals) 49908-118 49908-118-14 14 POUCH in 1 CARTON (49908-118-14) > 1.2 mL in 1 POUCH (49908-118-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.1%
Approval Date:Jan 5, 2016TE:ABRLD:No

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