FDA.reportPublic FDA data

Application 211527

Type
NDA
Sponsor
GALDERMA R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AKLIEFTRIFAROTENECREAM;TOPICAL0.005%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5935AKLIEFtrifaroteneGalderma Laboratories, L.P.NDACurrent
0299-5935AKLIEFtrifaroteneGalderma Laboratories, L.P.NDACurrent
0299-5935AKLIEFtrifaroteneGalderma Laboratories, L.P.NDACurrent
0299-5935AKLIEFtrifaroteneGalderma Laboratories, L.P.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71609SUPPL2022-07-20
71607SUPPL2022-07-20
60613ORIG2019-10-21
60596ORIG2019-10-08
60595ORIG2019-10-08
63272ORIG1900-01-01