Ivermectin Topical Lotion

Brand(s)
Sklice
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi Pasteur Inc. (2012-02-17)
Oldest Current Product
2012-07-09
License(s)
NDA
RxNORM
TOPICAL LOTION\IVERMECTIN
FDAOB
TOPICAL\LOTION\IVERMECTIN
SPL Active
TOPICAL\LOTION\IVERMECTIN
SPL Moiety
TOPICAL\LOTION\IVERMECTIN

product(s) by strength(s)

ivermectin 5 mg/ml topical lotion

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492810183SkliceNDASanofi Pasteur Inc.2012-07-09IVERMECTINTOPICALLOTIONNDA2027364c5557cd-c4cf-11df-851a-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202736SKLICESANOFI PASTEUR INC2012-02-07p6103248, SUBSTANCE
p8791153, SUBSTANCE
NEW PRODUCT [2015-02-07]NDA202736_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202736_001RXIVERMECTIN (0.5%)TOPICALLOTIONTrue2012-02-07SKLICE

patent(s)

#idexpiration dateapplication(s)
1p6103248 (view patent)2018-05-22NDA202736
2p8791153 (view patent)2027-10-12NDA202736

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14c5557cd-c4cf-11df-851a-0800200c9a66 (view SPL)These highlights do not include all the information needed to use SKLICE Lotion safely and effectively. See full prescribing information for SKLICE Lotion. SKLICE (ivermectin) Lotion, 0.5%for topical use Initial U.S. Approval: 1996prescriptionHuman PrescriptionSanofi Pasteur Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE2012-02-173492810183

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