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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020380

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NDA 020380 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from eight 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. Additional details are available on the adapalene profile page.

Summary for 020380

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020380

Ingredient-typeRetinoids

Medical Subject Heading (MeSH) Categories for 020380

Suppliers and Packaging for NDA: 020380

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFFERIN adapalene GEL;TOPICAL 020380 NDA Galderma Laboratories, L.P. 0299-4910 0299-4910-15 1 TUBE in 1 CARTON (0299-4910-15) > 15 g in 1 TUBE
DIFFERIN adapalene GEL;TOPICAL 020380 NDA Galderma Laboratories, L.P. 0299-4910 0299-4910-00 1 TUBE in 1 BLISTER PACK (0299-4910-00) > 2 g in 1 TUBE

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:GEL;TOPICALStrength0.1%
Approval Date:Jul 8, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 8, 2019
Regulatory Exclusivity Use:RX TO OTC SWITCH OR OTC USE


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