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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

Tradename:
DIFFERIN
Applicant:
Galderma Labs Lp
Ingredient:
adapalene
Patents:6
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021753

Ingredient-typeRetinoids

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

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?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS

Expired Orange Book Patents for NDA: 021753

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