Ivermectin Topical Cream

Brand(s)
Soolantra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Galderma Laboratories, L.P. (2014-12-20)
Oldest Current Product
2015-01-01
License(s)
NDA
RxNORM
TOPICAL CREAM\IVERMECTIN
FDAOB
TOPICAL\CREAM\IVERMECTIN
SPL Active
TOPICAL\CREAM\IVERMECTIN
SPL Moiety
TOPICAL\CREAM\IVERMECTIN

product(s) by strength(s)

ivermectin 10 mg/ml topical cream

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002993823SoolantraNDAGalderma Laboratories, L.P.2015-01-01IVERMECTINTOPICALCREAMNDA206255b1d5b166-ab06-4ab5-b0c6-31126238118a

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206255SOOLANTRAGALDERMA LABORATORIES LP2014-12-19p8093219, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA., SUBSTANCE
p5952372, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
p6133310, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
p8470788, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA., SUBSTANCE
p8080530, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA., SUBSTANCE
p7550440, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA., SUBSTANCE
p8415311, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA., SUBSTANCE
p9089587, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
p8815816, TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA., SUBSTANCE
NEW PRODUCT [2017-12-19]NDA206255_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206255_001RXIVERMECTIN (1%)TOPICALCREAMTrue2014-12-19SOOLANTRA

patent(s)

#idexpiration dateapplication(s)
1p5952372 (view patent)2018-09-18NDA206255
2p6133310 (view patent)2019-04-26NDA206255
3p7550440 (view patent)2024-04-22NDA206255
4p8080530 (view patent)2024-04-22NDA206255
5p8093219 (view patent)2024-04-22NDA206255
6p8415311 (view patent)2024-04-22NDA206255
7p8470788 (view patent)2024-04-22NDA206255
8p8815816 (view patent)2024-04-22NDA206255
9p9089587 (view patent)2034-03-13NDA206255

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b1d5b166-ab06-4ab5-b0c6-31126238118a (view SPL)These highlights do not include all the information needed to use SOOLANTRA safely and effectively. See full prescribing information for SOOLANTRA.SOOLANTRA (ivermectin) cream, 1%, for topical useInitial U.S. Approval: 1996prescriptionHuman PrescriptionGalderma Laboratories, L.P.manufacture2014-12-202002993823

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