Application 022502

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFFERINADAPALENELOTION;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5912DifferinadapaleneGalderma Laboratories, L.P.NDACurrent
0299-5912DifferinadapaleneGalderma Laboratories, L.P.NDACurrent
0299-5912DifferinadapaleneGalderma Laboratories, L.P.NDACurrent
69007-912adapaleneadapaleneOwen Laboratories, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74032SUPPL 2023-04-20
74030SUPPL 2023-04-20
71942SUPPL2022-08-29
29787SUPPL2013-04-23
17649SUPPL2013-04-23
24325ORIG2010-08-30
22037ORIG2010-08-30
7464ORIG2010-03-22
38768ORIG2010-03-18
53156ORIG1900-01-01
53155ORIG1900-01-01
53154ORIG1900-01-01