Details for New Drug Application (NDA): 022320
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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 |
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: | ⤷ Sign Up | Patent Expiration: | Nov 23, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 1, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF ACNE | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 18, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF ACNE |
Expired US Patents for NDA 022320
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 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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