efinaconazole Topical Solution

Brand(s)
Jublia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2015-02-27)
Oldest Current Product
2014-06-06
License(s)
NDA
RxNORM
TOPICAL SOLUTION\EFINACONAZOLE
FDAOB
TOPICAL\SOLUTION\EFINACONAZOLE
SPL Active
TOPICAL\SOLUTION\EFINACONAZOLE
SPL Moiety
TOPICAL\SOLUTION\EFINACONAZOLE

product(s) by strength(s)

efinaconazole 100 mg/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001875400JubliaNDAValeant Pharmaceuticals North America Llc2014-06-06EFINACONAZOLETOPICALSOLUTIONNDA203567922d4d25-c530-11e1-9b21-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203567JUBLIADOW PHARMACEUTICAL SCIENCES2014-06-06p8039494, ANTIMYCOTIC USES
p8486978, SUBSTANCE
p7214506, ANTIMYCOTIC USES
NEW CHEMICAL ENTITY [2019-06-06]NDA203567_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203567_001RXEFINACONAZOLE (10%)TOPICALSOLUTIONTrue2014-06-06JUBLIA

patent(s)

#idexpiration dateapplication(s)
1p7214506 (view patent)2021-10-05NDA203567
2p8039494 (view patent)2030-07-08NDA203567
3p8486978 (view patent)2030-10-24NDA203567

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1922d4d25-c530-11e1-9b21-0800200c9a66 (view SPL)These highlights do not include all the information needed to use JUBLIA safely and effectively. See full prescribing information for JUBLIA. JUBLIA (efinaconazole) topical solution, 10%For topical useInitial U.S. Approval: 2014prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE, PACK2015-02-274001875400

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