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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 seven 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 eleven drug master file entries for this compound. Seventeen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the adapalene profile page.

Summary for NDA: 021753

Galderma Labs Lp
Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 021753


Suppliers and Packaging for NDA: 021753

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEL;TOPICAL 021753 NDA Galderma Laboratories, L.P. 0299-5918 0299-5918-02 2 g in 1 TUBE (0299-5918-02)
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.3%
Approval Date:Jun 19, 2007TE:ABRLD:Yes
Patent:7,737,181Patent Expiration:Aug 29, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:7,838,558Patent Expiration:Mar 12, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,579,377Patent Expiration:Feb 23, 2025Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021753

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
GEL;TOPICAL021753-001Jun 19, 20074,717,720<subscribe>
Galderma Labs Lp
GEL;TOPICAL021753-001Jun 19, 2007RE34440<subscribe>
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