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Last Updated: September 26, 2022

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 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-five suppliers are listed for this compound. Additional details are available on the adapalene profile page.
Summary for 020380
Applicant:Galderma Labs Lp
Formulation / Manufacturing:see details
Pharmacology for NDA: 020380
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 0299-4910-00 1 TUBE in 1 BLISTER PACK (0299-4910-00) > 2 g in 1 TUBE
DIFFERIN adapalene GEL;TOPICAL 020380 NDA Galderma Laboratories, L.P. 0299-4910 0299-4910-10 1 BOTTLE, PUMP in 1 CARTON (0299-4910-10) > 15 g in 1 BOTTLE, PUMP

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:GEL;TOPICALStrength0.1%
Approval Date:Jul 8, 2016TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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