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Serving leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Boehringer Ingelheim
Daiichi Sankyo

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204153

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NDA 204153 describes LUZU, which is a drug marketed by Medicis and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the LUZU profile page.

The generic ingredient in LUZU is luliconazole. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the luliconazole profile page.

Summary for 204153


Pharmacology for NDA: 204153

Mechanism of ActionCytochrome P450 2C19 Inhibitors

Suppliers and Packaging for NDA: 204153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUZU luliconazole CREAM;TOPICAL 204153 NDA Valeant Pharmaceuticals North America LLC 99207-850 99207-850-60 1 TUBE in 1 CARTON (99207-850-60) > 60 g in 1 TUBE
LUZU luliconazole CREAM;TOPICAL 204153 NDA Valeant Pharmaceuticals North America LLC 99207-850 99207-850-02 12 TUBE in 1 CARTON (99207-850-02) > 2 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Nov 14, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 14, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Jan 18, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Apr 28, 2034Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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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