Application 215309

Type
NDA
Sponsor
INCYTE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPZELURARUXOLITINIBCREAM;TOPICAL1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50881-007OPZELURAruxolitinibIncyte CorporationNDACurrent
50881-007OPZELURAruxolitinibIncyte CorporationNDACurrent
50881-007OPZELURAruxolitinibIncyte CorporationNDACurrent
50881-007OPZELURAruxolitinibIncyte CorporationNDACurrent
50881-007OPZELURAruxolitinibIncyte CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85858SUPPL 2026-05-11
83398SUPPL 2025-09-19
83397SUPPL 2025-09-19
83395SUPPL 2025-09-19
73759SUPPL 2023-03-14
73741SUPPL 2023-03-14
71593SUPPL2022-07-19
71592SUPPL2022-07-19
71589SUPPL2022-07-19
71552ORIG2022-07-14
71520ORIG2022-07-06
68716ORIG2021-09-22