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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 eight 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 eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

Summary for NDA: 207917

Tradename:
EPIDUO FORTE
Applicant:
Galderma Labs
Ingredient:
adapalene; benzoyl peroxide
Patents:8
Formulation / Manufacturing:see details

Pharmacology for NDA: 207917

Ingredient-typeRetinoids

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 0299-5906-02 1 TUBE in 1 BLISTER PACK (0299-5906-02) > 2 g in 1 TUBE
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL 207917 NDA Galderma Laboratories, L.P. 0299-5906 0299-5906-05 1 TUBE in 1 BLISTER PACK (0299-5906-05) > 5 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%;2.5%
Approval Date:Jul 15, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 15, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Patent:8,445,543Patent Expiration:Jul 12, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:8,703,820Patent Expiration:Mar 12, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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