FDA.reportPublic FDA data

Application 020748

Type
NDA
Sponsor
GALDERMA LABS LP

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-5915DifferinAdapaleneGALDERMA LABORATORIES, L.PNDACurrent
0299-5915DifferinAdapaleneGALDERMA LABORATORIES, L.PNDACurrent
0299-5915DifferinAdapaleneGALDERMA LABORATORIES, L.PNDACurrent
45802-453AdapaleneAdapalenePerrigo New York IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20897ORIG2003-05-08
35269ORIG2000-05-26
25697ORIG2000-05-26