FDA.reportPublic FDA data

Application 207071

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FINACEAAZELAIC ACIDAEROSOL, FOAM;TOPICAL15%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50222-303FINACEA FOAMazelaic acidLEO Pharma Inc.NDACurrent
50222-303FINACEA FOAMazelaic acidLEO Pharma Inc.NDACurrent
50419-829FINACEA FOAMazelaic acidBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-829FINACEA FOAMazelaic acidBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65462SUPPL2020-12-02
65461SUPPL2020-12-02
65455SUPPL2020-12-01
65454SUPPL2020-12-01
44955ORIG2016-04-13
43532ORIG2016-04-13
19956ORIG2015-08-04
32843ORIG2015-07-31