tavaborole Topical Solution

Brand(s)
Kerydin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Anacor Pharmaceuticals, Inc (2015-01-20)
Oldest Current Product
2014-07-07
License(s)
NDA
RxNORM
TOPICAL SOLUTION\TAVABOROLE
FDAOB
TOPICAL\SOLUTION\TAVABOROLE
SPL Active
TOPICAL\SOLUTION\TAVABOROLE
SPL Moiety
TOPICAL\SOLUTION\TAVABOROLE

product(s) by strength(s)

tavaborole 43.5 mg/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1557240111KerydinNDAAnacor Pharmaceuticals, Inc2014-07-07TAVABOROLETOPICALSOLUTIONNDA204427f6ba6f49-0055-4285-9e04-67001d4554fd

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204427KERYDINANACOR PHARMACEUTICALS INC2014-07-07p7767657, SUBSTANCE
p7582621, TREATMENT OF FUNGAL INFECTIONS
NEW CHEMICAL ENTITY [2019-07-07]NDA204427_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204427_001RXTAVABOROLE (5%)TOPICALSOLUTIONTrue2014-07-07KERYDIN

patent(s)

#idexpiration dateapplication(s)
1p7582621 (view patent)2027-05-26NDA204427
2p7767657 (view patent)2027-05-22NDA204427

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
11ae61072-bca0-43f0-a741-07bda2d50c87 (view SPL)These highlights do not include all the information needed to use KERYDIN safely and effectively. See full prescribing information for KERYDIN.KERYDIN (tavaborole) topical solution, 5%INITIAL U.S. APPROVAL: 2014prescriptionHuman PrescriptionPharmaderm A Division Of Fougera Pharmaceuticals Inc.2015-03-131103370905
2f6ba6f49-0055-4285-9e04-67001d4554fd (view SPL)These highlights do not include all the information needed to use KERYDIN safely and effectively. See full prescribing information for KERYDIN.KERYDIN (tavaborole) topical solution, 5%INITIAL U.S. APPROVAL: 2014prescriptionHuman PrescriptionAnacor Pharmaceuticals, Inc2015-01-204557240111

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