FDA.reportPublic FDA data

Application 021112

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRI-LUMAFLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOINCREAM;TOPICAL0.01%;4%;0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5950TRI-LUMAfluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDACurrent
0299-5950TRI-LUMAfluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDACurrent
0299-5950TRI-LUMAfluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDACurrent
0299-5950TRI-LUMAfluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDACurrent
0299-5950TRI-LUMAfluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDACurrent
0299-5950TRI-LUMAfluocinolone acetonide, hydroquinone, and tretinoinGalderma Laboratories, L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
26802SUPPL2014-04-02
14417SUPPL2014-04-01
4366SUPPL2013-01-28
36147SUPPL2013-01-22
4365SUPPL2012-12-26
41956ORIG2002-03-26
14416ORIG2002-01-18