Details for New Drug Application (NDA): 021753

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NDA 021753 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. Forty suppliers are listed for this compound. Additional details are available on the adapalene profile page.

Summary for 021753

Tradename:	DIFFERIN
Applicant:	Galderma Labs Lp
Ingredient:	adapalene
Patents:	2

Pharmacology for NDA: 021753

Medical Subject Heading (MeSH) Categories for 021753

Anti-Inflammatory Agents, Non-Steroidal
Dermatologic Agents

Suppliers and Packaging for NDA: 021753

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFFERIN	adapalene	GEL;TOPICAL	021753	NDA	Galderma Laboratories, L.P.	0299-5918	0299-5918-25	1 BOTTLE, PUMP in 1 CARTON (0299-5918-25) / 45 g in 1 BOTTLE, PUMP
DIFFERIN	adapalene	GEL;TOPICAL	021753	NDA AUTHORIZED GENERIC	Mayne Pharma Commercial LLC.	68308-666	68308-666-25	1 TUBE in 1 CARTON (68308-666-25) / 45 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TOPICAL			Strength	0.3%
Approval Date:	Jun 19, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 23, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS
Patent:	⤷ Sign Up	Patent Expiration:	Aug 29, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021753

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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