FDA.reportPublic FDA data

Application 207589

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENSTILARBETAMETHASONE DIPROPIONATE; CALCIPOTRIENEAEROSOL, FOAM;TOPICAL0.064%;0.005%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-302ENSTILARcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68327SUPPL2021-08-10
68315SUPPL2021-08-09
64958SUPPL2020-10-21
64942SUPPL2020-10-20
59544SUPPL2019-08-01
59543SUPPL2019-08-01
59542SUPPL2019-08-01
59524SUPPL2019-07-31
59523SUPPL2019-07-31
59522SUPPL2019-07-31
43534ORIG2016-05-04
24527ORIG2016-05-04
19966SUPPL2016-03-14
32857SUPPL2016-03-10
19965ORIG2015-10-22
10620ORIG2015-10-20
62876SUPPL1900-01-01