FDA.reportPublic FDA data

Application 211122

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL48MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL145MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42385-950fenofibratefenofibrateLaurus Labs LimitedANDACurrent
42385-950fenofibratefenofibrateLaurus Labs LimitedANDACurrent
42385-950fenofibratefenofibrateLaurus Labs LimitedANDACurrent
42385-951fenofibratefenofibrateLaurus Labs LimitedANDACurrent
42385-951fenofibratefenofibrateLaurus Labs LimitedANDACurrent
42385-951fenofibratefenofibrateLaurus Labs LimitedANDACurrent
69315-287fenofibratefenofibrateLeading Pharma, LLCANDACurrent
69315-288fenofibratefenofibrateLeading Pharma, LLCANDACurrent
69844-012fenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-012fenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-012fenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-013fenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-013fenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-013fenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent