FDA.reportPublic FDA data

Application 207564

Type
ANDA
Sponsor
NOVAST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL67MGNoNo
002FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL134MGNoNo
003FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-201FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-201FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-201FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-202FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-202FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-202FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-203FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-203FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent
50742-203FENOFIBRATEFENOFIBRATEIngenus Pharmaceuticals, LLCANDACurrent