FDA.reportPublic FDA data

Application 020380

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DIFFERINADAPALENEGEL;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-4910DifferinAdapaleneGalderma Laboratories, L.P.NDACurrent
0299-4910DifferinAdapaleneGalderma Laboratories, L.P.NDACurrent
0299-4910DifferinAdapaleneGalderma Laboratories, L.P.NDACurrent
0299-4910DifferinAdapaleneGalderma Laboratories, L.P.NDACurrent
0299-4910DifferinAdapaleneGalderma Laboratories, L.P.NDACurrent
0299-4910DifferinAdapaleneGalderma Laboratories, L.P.NDACurrent
0299-5910DIFFERINadapaleneGalderma Laboratories, L.P.NDACurrent
11410-956Proactiv MD AdapaleneAdapaleneThe Proactiv Company, LLCNDA AUTHORIZED GENERICCurrent
11410-956Proactiv MD AdapaleneAdapaleneAlchemee, LLCNDA AUTHORIZED GENERICCurrent
51672-4155AdapaleneAdapaleneTaro Pharmaceuticals U.S.A., Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79546SUPPL 2024-09-06
71314SUPPL2022-06-15
53507SUPPL2018-03-29
53497SUPPL2018-03-28
49900SUPPL2017-10-02
48538SUPPL2017-05-25
48505SUPPL2017-05-24
47776SUPPL2017-03-30
47775SUPPL2017-03-30