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Last Updated: July 14, 2020

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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 six 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
Generic Entry Opportunity Date for 204153
Generic Entry Date for 204153*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 204153
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 Oceanside Pharmaceuticals 68682-850 68682-850-60 1 TUBE in 1 CARTON (68682-850-60) > 60 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Nov 14, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 20, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Jan 18, 2020Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Apr 28, 2034Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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