Details for New Drug Application (NDA): 020338

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NDA 020338 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from four suppliers. There are three 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 020338

Tradename:	DIFFERIN
Applicant:	Galderma Labs Lp
Ingredient:	adapalene
Patents:	0

Medical Subject Heading (MeSH) Categories for 020338

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 31, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020338

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996	⤷ Start Trial	⤷ Start Trial
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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