FDA.reportPublic FDA data

Application 209913

Type
ANDA
Sponsor
ENCUBE ETHICALS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDESOLUTION;TOPICAL0.01%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21922-003Fluocinolone Acetonide Topical Solution USP, 0.01%Fluocinolone Acetonide Topical Solution USP, 0.01%Encube Ethicals Private LimitedANDACurrent
21922-003Fluocinolone Acetonide Topical Solution USP, 0.01%Fluocinolone Acetonide Topical Solution USP, 0.01%Encube Ethicals Private LimitedANDACurrent
63629-9584Fluocinolone Acetonide Topical Solution USP, 0.01%Fluocinolone Acetonide Topical Solution USP, 0.01%Bryant Ranch PrepackANDACurrent