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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203981


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NDA 203981 describes ADAPALENE, which is a drug marketed by Fougera Pharms, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Generics, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, and Zydus Pharms, and is included in twenty NDAs. It is available from thirty-three 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. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Summary for 203981
Tradename:ADAPALENE
Applicant:Call Inc
Ingredient:adapalene
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203981
Medical Subject Heading (MeSH) Categories for 203981
Suppliers and Packaging for NDA: 203981
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADAPALENE adapalene SOLUTION;TOPICAL 203981 ANDA CALL INC (d.b.a Rochester Pharmaceuticals) 49908-117 49908-117-70 120 mL in 1 CARTON (49908-117-70)
ADAPALENE adapalene SOLUTION;TOPICAL 203981 ANDA Allegis Holdings LLC 71297-410 71297-410-02 1 BOTTLE, GLASS in 1 CARTON (71297-410-02) / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength0.1%
Approval Date:Sep 23, 2016TE:ABRLD:No

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