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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 022502


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NDA 022502 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from four suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DIFFERIN profile page.

The generic ingredient in DIFFERIN is adapalene. There are twelve drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the adapalene profile page.
Summary for 022502
Tradename:DIFFERIN
Applicant:Galderma Labs Lp
Ingredient:adapalene
Patents:3
Pharmacology for NDA: 022502
Medical Subject Heading (MeSH) Categories for 022502
Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents
Suppliers and Packaging for NDA: 022502
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFFERIN adapalene LOTION;TOPICAL 022502 NDA Galderma Laboratories, L.P. 0299-5912 0299-5912-01 15 mL in 1 BOTTLE (0299-5912-01)
DIFFERIN adapalene LOTION;TOPICAL 022502 NDA Galderma Laboratories, L.P. 0299-5912 0299-5912-02 1 BOTTLE, PUMP in 1 CARTON (0299-5912-02) / 59 mL in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:LOTION;TOPICALStrength0.1%
Approval Date:Mar 17, 2010TE:RLD:Yes
Patent:⤷  Get Started FreePatent Expiration:May 31, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:⤷  Get Started FreePatent Expiration:Sep 15, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:⤷  Get Started FreePatent Expiration:Sep 15, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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