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Last Updated: April 16, 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-eight suppliers are listed for this compound. Additional details are available on the adapalene profile page.

Summary for 020748

Tradename:	DIFFERIN
Applicant:	Galderma Labs Lp
Ingredient:	adapalene
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020748

Medical Subject Heading (MeSH) Categories for 020748

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

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:	RX	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	May 26, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020748

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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