Details for New Drug Application (NDA): 207917

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NDA 207917 describes EPIDUO FORTE, which is a drug marketed by Galderma Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the EPIDUO FORTE profile page.

The generic ingredient in EPIDUO FORTE 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 207917

Tradename:	EPIDUO FORTE
Applicant:	Galderma Labs
Ingredient:	adapalene; benzoyl peroxide
Patents:	0

Pharmacology for NDA: 207917

Suppliers and Packaging for NDA: 207917

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917	NDA	Galderma Laboratories, L.P.	0299-5906	0299-5906-00	2 g in 1 TUBE (0299-5906-00)
EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917	NDA	Galderma Laboratories, L.P.	0299-5906	0299-5906-02	1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.3%;2.5%
Approval Date:	Jul 15, 2015	TE:	AB	RLD:	Yes

Expired US Patents for NDA 207917

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	9,814,690	⤷ Subscribe
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	8,809,305	⤷ Subscribe
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	9,387,187	⤷ Subscribe
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	8,445,543	⤷ Subscribe
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	8,936,800	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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