Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
McKesson
Chubb
Moodys
Accenture
Novartis
Deloitte
Julphar
Mallinckrodt
Fuji

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020380

« Back to Dashboard
NDA 020380 describes DIFFERIN, which is a drug marketed by Galderma Labs Lp and is included in five NDAs. It is available from eight suppliers. There are nine 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 eleven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the adapalene profile page.

Summary for NDA: 020380

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020380

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 020380

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFFERIN
adapalene
GEL;TOPICAL 020380 NDA Galderma Laboratories, L.P. 0299-4910 0299-4910-00 1 TUBE in 1 BLISTER PACK (0299-4910-00) > 2 g in 1 TUBE
DIFFERIN
adapalene
GEL;TOPICAL 020380 NDA Galderma Laboratories, L.P. 0299-4910 0299-4910-15 1 TUBE in 1 CARTON (0299-4910-15) > 15 g in 1 TUBE

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:GEL;TOPICALStrength0.1%
Approval Date:Jul 8, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 8, 2019
Regulatory Exclusivity Use:RX TO OTC SWITCH OR OTC USE


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
McKesson
Fuji
Dow
Moodys
Mallinckrodt
Colorcon
Cantor Fitzgerald
Chubb
Harvard Business School

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 verifification 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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot