FDA.reportPublic FDA data

Application 207803

Type
ANDA
Sponsor
AUSTARPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL54MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL160MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35561-343FenofibrateFenofibrateAustarPharma LLCANDACurrent
35561-344FenofibrateFenofibrateAustarPharma LLCANDACurrent
69367-254FenofibrateFenofibrateWestminster Pharmaceuticals, LLCANDACurrent
69367-254FenofibrateFenofibrateWestminster Pharmaceuticals, LLCANDACurrent
69367-254FenofibrateFenofibrateWestminster Pharmaceuticals, LLCANDACurrent
69367-257FenofibrateFenofibrateWestminster Pharmaceuticals, LLCANDACurrent
69367-257FenofibrateFenofibrateWestminster Pharmaceuticals, LLCANDACurrent
69367-257FenofibrateFenofibrateWestminster Pharmaceuticals, LLCANDACurrent
71205-949FenofibrateFenofibrateProficient Rx LPANDACurrent
71205-949FenofibrateFenofibrateProficient Rx LPANDACurrent