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Last Updated: April 19, 2024

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. Thirty-eight 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
Formulation / Manufacturing:	see details

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:	⤷ Try a Trial	Patent Expiration:	Feb 23, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACNE VULGARIS
Patent:	⤷ Try a Trial	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	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Try a Trial	⤷ Try a Trial
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.