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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 fifteen 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 eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Summary for NDA: 022320

Tradename:
EPIDUO
Applicant:
Galderma Labs Lp
Ingredient:
adapalene; benzoyl peroxide
Patents:10
Formulation / Manufacturing:see details

Pharmacology for NDA: 022320

Ingredient-typeRetinoids

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.1%;2.5%
Approval Date:Dec 8, 2008TE:ABRLD:Yes
Patent:7,820,186Patent Expiration:Nov 23, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:8,241,649Patent Expiration:Dec 23, 2022Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Feb 1, 2016
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 022320

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 20084,717,720► subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008RE34440► subscribe
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