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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 four 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 NDA: 204153


Pharmacology for NDA: 204153


Suppliers and Packaging for NDA: 204153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Nov 14, 2013TE:RLD:Yes
Patent:8,980,931Patent Expiration:Apr 28, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:9,199,977Patent Expiration:Sep 6, 2033Product Flag?YSubstance Flag?YDelist Request?
Patent:9,453,006Patent Expiration:Sep 6, 2033Product Flag?Substance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 204153

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CREAM;TOPICAL204153-001Nov 14, 20135,900,488<disabled>
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