FDA.reportPublic FDA data

Application 202833

Type
NDA
Sponsor
LEO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PICATOINGENOL MEBUTATEGEL;TOPICAL0.015%YesYes
002PICATOINGENOL MEBUTATEGEL;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50222-502Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-502Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-502Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-502Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-502Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-502Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-503Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-503Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-503Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-503Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-503Picatoingenol mebutateLEO Pharma Inc.NDACurrent
50222-503Picatoingenol mebutateLEO Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66847SUPPL2021-03-24
66826SUPPL2021-03-22
65717SUPPL2020-12-23
65619SUPPL2020-12-17
61894SUPPL2020-02-14
61888SUPPL2020-02-14
57652SUPPL2019-02-15
45405SUPPL2016-09-15
45326SUPPL2016-09-15
40230SUPPL2015-11-25
10118SUPPL2015-11-20
19388SUPPL2015-10-08
10119SUPPL2015-10-07
40229SUPPL2014-03-26
32321SUPPL2014-03-14
43416ORIG2012-03-02
32320ORIG2012-01-30
19387ORIG2012-01-25