FDA.reportPublic FDA data

Application 207538

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOCINONIDEFLUOCINONIDEOINTMENT;TOPICAL0.05%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-095FluocinonideFluocinonideNovel Laboratories, Inc.ANDACurrent
43386-095FluocinonideFluocinonideLupin Pharmaceuticals,Inc.ANDACurrent