Details for New Drug Application (NDA): 207917
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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 |
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
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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