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:	RX	Dosage:	GEL;TOPICAL			Strength	0.1%;2.5%
Approval Date:	Dec 8, 2008	TE:	AB	RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Nov 23, 2025	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Sep 1, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE
Patent:	⤷ Subscribe	Patent Expiration:	Jul 18, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE

Expired US Patents for NDA 022320

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

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