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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. Six 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: | 9 |
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 |
Paragraph IV (Patent) Challenges for 207917
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
EPIDUO FORTE | GEL;TOPICAL | adapalene; benzoyl peroxide | 207917 | 2016-05-04 |
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 | ||||
Patent: | Start Trial | Patent Expiration: | Dec 23, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ACNE | ||||||||
Patent: | Start Trial | Patent Expiration: | Mar 12, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ACNE | ||||||||
Patent: | Start Trial | Patent Expiration: | Mar 12, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ACNE |
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