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Details for New Drug Application (NDA): 207917
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 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 207917
Generic Entry Date for 207917*:
Constraining patent/regulatory exclusivity:
Dosage:
GEL;TOPICAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 207917
| Ingredient-type | Retinoids |
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 | N | 0299-5906-02 |
| EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917 | NDA | Galderma Laboratories, L.P. | 0299-5906 | N | 0299-5906-05 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 0.3%;2.5% | ||||
| Approval Date: | Jul 15, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 15, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Dec 23, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACNE | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Mar 12, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACNE | ||||||||
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