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Last Updated: November 2, 2024

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:RXDosage:GEL;TOPICALStrength0.3%;2.5%
Approval Date:Jul 15, 2015TE:ABRLD:Yes

Expired US Patents for NDA 207917

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 ⤷  Sign Up ⤷  Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 ⤷  Sign Up ⤷  Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 ⤷  Sign Up ⤷  Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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