FDA.reportPublic FDA data

Application 202849

Type
ANDA
Sponsor
PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOCINOLONE ACETONIDEFLUOCINOLONE ACETONIDEOIL/DROPS;OTIC0.01%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-009Fluocinolone AcetonideFluocinolone AcetonidePerrigo New York IncANDACurrent
45802-009Fluocinolone AcetonideFluocinolone AcetonidePadagis Israel Pharmaceuticals LtdANDACurrent