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Last Updated: November 21, 2024

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 five 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. Thirteen 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:5
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%;2.5%
Approval Date:Dec 8, 2008TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 23, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:⤷  Sign UpPatent Expiration:Jul 18, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

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

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