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Last Updated: May 27, 2024

Details for New Drug Application (NDA): 020748

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NDA 020748 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 five 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the adapalene profile page.
Summary for 020748
Applicant:Galderma Labs Lp
Formulation / Manufacturing:see details
Pharmacology for NDA: 020748
Medical Subject Heading (MeSH) Categories for 020748
Suppliers and Packaging for NDA: 020748
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFFERIN adapalene CREAM;TOPICAL 020748 NDA GALDERMA LABORATORIES, L.P 0299-5915 0299-5915-45 1 TUBE in 1 CARTON (0299-5915-45) / 45 g in 1 TUBE
DIFFERIN adapalene CREAM;TOPICAL 020748 NDA AUTHORIZED GENERIC Padagis Israel Pharmaceuticals Ltd 45802-453 45802-453-84 1 TUBE in 1 CARTON (45802-453-84) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:May 26, 2000TE:ABRLD:Yes

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