Benzyl Alcohol Topical Lotion

Brand(s)
Ulesfia
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shionogi Inc. (2012-07-12)
Oldest Current Product
2009-05-26
License(s)
NDA
RxNORM
TOPICAL LOTION\BENZYL ALCOHOL
FDAOB
TOPICAL\LOTION\BENZYL ALCOHOL
SPL Active
TOPICAL\LOTION\BENZYL ALCOHOL
SPL Moiety
TOPICAL\LOTION\BENZYL ALCOHOL

product(s) by strength(s)

benzyl alcohol 0.05 ml/ml topical lotion

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1592120780UlesfiaNDAConcordia Pharmaceuticals Inc.2009-05-26BENZYL ALCOHOLTOPICALLOTIONNDA022129aeba2488-1ac3-4c02-833c-78a36859f029
2596300780UlesfiaNDAShionogi Inc.2009-05-26BENZYL ALCOHOLTOPICALLOTIONNDA02212980fb32ee-ed0f-4060-9eb0-b5847b3676c6

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA022129ULESFIASHIONOGI INC2009-04-09p7294342, TOPICAL TREATMENT OF LICE INFESTATIONS
p5858383, TOPICAL TREATMENT OF LICE INFESTATIONS
p6793931, TOPICAL TREATMENT OF LICE INFESTATIONS, SUBSTANCE
p6139859, TOPICAL TREATMENT OF LICE INFESTATIONS
NDA022129_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022129_001RXBENZYL ALCOHOL (5%)TOPICALLOTIONTrue2009-04-09ULESFIA

patent(s)

#idexpiration dateapplication(s)
1p5858383 (view patent)2017-08-11NDA022129
2p6139859 (view patent)2017-08-11NDA022129
3p6793931 (view patent)2022-07-11NDA022129
4p7294342 (view patent)2024-05-19NDA022129

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
15754f979-32b7-4406-a3a9-ed36aac6a37a (view SPL)These highlights do not include all the information needed to use ULESFIA safely and effectively. See full prescribing information for ULESFIA. ULESFIA (benzyl alcohol) lotion, for topical use Initial U.S. Approval: 2009prescriptionHuman PrescriptionZylera Pharmaceuticals, Llc2014-07-161235940780
280fb32ee-ed0f-4060-9eb0-b5847b3676c6 (view SPL)These highlights do not include all the information needed to use ULESFIA safely and effectively. See full prescribing information for ULESFIA . ULESFIA (benzyl alcohol) l otion , f or topical use Initial U.S. Approval: 200 9prescriptionHuman PrescriptionShionogi Inc.2012-07-1215596300780
3aeba2488-1ac3-4c02-833c-78a36859f029 (view SPL)These highlights do not include all the information needed to use ULESFIA safely and effectively. See full prescribing information for ULESFIA . ULESFIA (benzyl alcohol) l otion , f or topical use Initial U.S. Approval: 200 9prescriptionHuman PrescriptionConcordia Pharmaceuticals Inc.2014-01-211592120780

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