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Generated: December 18, 2017

DrugPatentWatch Database Preview

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 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. Seventeen suppliers are listed for this compound. Additional details are available on the adapalene profile page.

Summary for 020748

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

Pharmacology for NDA: 020748

Ingredient-typeRetinoids

Medical Subject Heading (MeSH) Categories for 020748

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 45 g in 1 TUBE (0299-5915-45)
DIFFERIN adapalene CREAM;TOPICAL 020748 NDA Perrigo New York Inc 45802-453 45802-453-84 1 TUBE in 1 CARTON (45802-453-84) > 45 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.1%
Approval Date:May 26, 2000TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020748

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs LpDIFFERINadapaleneCREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneCREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
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US Army
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AstraZeneca

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.

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