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Last Updated: February 1, 2023

Details for New Drug Application (NDA): 021753


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NDA 021753 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from five suppliers. There are nine 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. Twenty-six suppliers are listed for this compound. Additional details are available on the adapalene profile page.
Summary for 021753
Tradename:DIFFERIN
Applicant:Galderma Labs Lp
Ingredient:adapalene
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 021753
Medical Subject Heading (MeSH) Categories for 021753
Suppliers and Packaging for NDA: 021753
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFFERIN adapalene GEL;TOPICAL 021753 NDA Galderma Laboratories, L.P. 0299-5918 0299-5918-02 2 g in 1 TUBE (0299-5918-02)
DIFFERIN adapalene GEL;TOPICAL 021753 NDA Galderma Laboratories, L.P. 0299-5918 0299-5918-15 1 TUBE in 1 CARTON (0299-5918-15) / 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%
Approval Date:Jun 19, 2007TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 23, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS
Patent:See Plans and PricingPatent Expiration:Aug 29, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Mar 12, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired US Patents for NDA 021753

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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