FDA.reportPublic FDA data

Application 022185

Type
NDA
Sponsor
LEO PHARMA AS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TACLONEXBETAMETHASONE DIPROPIONATE; CALCIPOTRIENESUSPENSION;TOPICAL0.064%;0.005%YesYes
002TACLONEXBETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATESUSPENSION;TOPICAL0.064%;0.005%YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50222-501TACLONEXcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-501TACLONEXcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-501TACLONEXcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-501TACLONEXcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
50222-501TACLONEXcalcipotriene and betamethasone dipropionateLEO Pharma Inc.NDACurrent
66993-937Calcipotriene and Betamethasone DipropionateCalcipotriene and Betamethasone DipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-937Calcipotriene and Betamethasone DipropionateCalcipotriene and Betamethasone DipropionatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59484SUPPL2019-07-29
57695SUPPL2019-02-19
38351SUPPL2016-06-23
38350SUPPL2015-11-04
38349SUPPL2014-09-03
29370SUPPL2014-09-03
29371SUPPL2014-07-29
17053SUPPL2014-07-29
38347SUPPL2013-11-19
38348SUPPL2013-11-08
29369SUPPL2013-11-08
7011SUPPL2013-11-08
17052SUPPL2012-12-04
7010SUPPL2012-12-04
29368SUPPL2012-10-22
38346SUPPL2012-10-18
21954ORIG2009-04-14
29367SUPPL2009-03-24
44695ORIG2008-07-17
29366ORIG2008-05-15
52076SUPPL1900-01-01
52075SUPPL1900-01-01
52074SUPPL1900-01-01