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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 one supplier. There are nine patents protecting this drug and one Paragraph IV challenge. 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. Six suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
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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