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Last Updated: July 29, 2021

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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-two suppliers are listed for this compound. Additional details are available on the adapalene profile page.
Summary for 021753
Applicant:Galderma Labs Lp
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
Paragraph IV (Patent) Challenges for 021753
Tradename Dosage Ingredient NDA Submissiondate
DIFFERIN GEL;TOPICAL adapalene 021753 2009-09-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%
Approval Date:Jun 19, 2007TE:ABRLD:Yes
Patent:⤷  Try it FreePatent Expiration:Feb 23, 2025Product Flag?Substance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Aug 29, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Mar 12, 2023Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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