FDA.reportPublic FDA data

Application 204708

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRVASOBRIMONIDINE TARTRATEGEL;TOPICALEQ 0.33% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5980Mirvasobrimonidine tartrateGalderma Laboratories, L.P.NDACurrent
0299-5980Mirvasobrimonidine tartrateGalderma Laboratories, L.P.NDACurrent
0299-5980Mirvasobrimonidine tartrateGalderma Laboratories, L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19589SUPPL2016-07-28
10383SUPPL2016-07-28
40415SUPPL2015-10-27
44907ORIG2014-03-14
43474ORIG2014-03-14
19588ORIG2013-08-27
10382ORIG2013-08-27