luliconazole Topical Cream

Brand(s)
Luzu
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Medicis, The Dermatology Company (2014-08-01)
Oldest Current Product
2013-11-14
License(s)
NDA
RxNORM
TOPICAL CREAM\LULICONAZOLE
FDAOB
TOPICAL\CREAM\LULICONAZOLE
SPL Active
TOPICAL\CREAM\LULICONAZOLE
SPL Moiety
TOPICAL\CREAM\LULICONAZOLE

product(s) by strength(s)

luliconazole 10 mg/ml topical cream

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1992070850LuzuNDAMedicis, The Dermatology Company2013-11-14LULICONAZOLETOPICALCREAMNDA204153a7016010-ce43-4c09-8d21-aeb697ffed31

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204153LUZUMEDICIS PHARMACEUTICAL CORP2013-11-14p8980931, SUBSTANCE
p9012484, TREATMENT OF FUNGAL INFECTIONS, SUBSTANCE
p5900488, TREATMENT OF FUNGAL INFECTIONS, SUBSTANCE
NEW CHEMICAL ENTITY [2018-11-14]NDA204153_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204153_001RXLULICONAZOLE (1%)TOPICALCREAMTrue2013-11-14LUZU

patent(s)

#idexpiration dateapplication(s)
1p5900488 (view patent)2016-07-05NDA204153
2p8980931 (view patent)2034-04-28NDA204153
3p9012484 (view patent)2033-09-06NDA204153

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a7016010-ce43-4c09-8d21-aeb697ffed31 (view SPL)These highlights do not include all the information needed to use LUZU safely and effectively. See full prescribing information for LUZU. LUZU (luliconazole) Cream, 1% for topical useInitial U.S. Approval: 2013prescriptionHuman PrescriptionMedicis, The Dermatology CompanyMANUFACTURE2014-08-012992070850

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII