FDA.reportPublic FDA data

Application 207805

Type
ANDA
Sponsor
AUSTARPHARMA

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
35561-345FenofibrateFENOFIBRATEAustarpharma, LLCANDACurrent
35561-345FenofibrateFENOFIBRATEAustarpharma, LLCANDACurrent
35561-346FenofibrateFENOFIBRATEAustarpharma, LLCANDACurrent
35561-346FenofibrateFENOFIBRATEAustarpharma, LLCANDACurrent
35561-347FenofibrateFENOFIBRATEAustarpharma, LLCANDACurrent
35561-347FenofibrateFENOFIBRATEAustarpharma, LLCANDACurrent
69367-268FenofibrateFENOFIBRATEWestminster Pharmaceuticals, LLCANDACurrent
69367-268FenofibrateFENOFIBRATEWestminster Pharmaceuticals, LLCANDACurrent
69367-269FenofibrateFENOFIBRATEWestminster Pharmaceuticals, LLCANDACurrent
69367-269FenofibrateFENOFIBRATEWestminster Pharmaceuticals, LLCANDACurrent
69367-270FenofibrateFENOFIBRATEWestminster Pharmaceuticals, LLCANDACurrent
69367-270FenofibrateFENOFIBRATEWestminster Pharmaceuticals, LLCANDACurrent