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Last Updated: January 24, 2021

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Details for New Drug Application (NDA): 022320

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NDA 022320 describes EPIDUO, which is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in two NDAs. It is available from two suppliers. There are sixteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the EPIDUO profile page.

The generic ingredient in EPIDUO 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 022320
Tradename:EPIDUO
Applicant:Galderma Labs Lp
Ingredient:adapalene; benzoyl peroxide
Patents:10
Pharmacology for NDA: 022320
Suppliers and Packaging for NDA: 022320
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320 NDA Galderma Laboratories, L.P. 0299-5908 0299-5908-00 1 TUBE in 1 BLISTER PACK (0299-5908-00) > 2 g in 1 TUBE
EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320 NDA Galderma Laboratories, L.P. 0299-5908 0299-5908-02 2 g in 1 TUBE (0299-5908-02)
Paragraph IV (Patent) Challenges for 022320
Tradename Dosage Ingredient NDA Submissiondate
EPIDUO GEL;TOPICAL adapalene; benzoyl peroxide 022320 2011-12-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%;2.5%
Approval Date:Dec 8, 2008TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 23, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 18, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022320

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008   Start Trial   Start Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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