FDA.reportPublic FDA data

Application 210606

Type
ANDA
Sponsor
GRAVITI PHARMS

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
42385-935FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
42385-935FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
42385-935FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
42385-935FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
42385-936FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
42385-936FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
42385-936FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
42385-936FENOFIBRATEFENOFIBRATELaurus Labs LimitedANDACurrent
69315-289FenofibrateFenofibrateLeading Pharma, LLCANDACurrent
69315-290FenofibrateFenofibrateLeading Pharma, LLCANDACurrent
69844-008FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-008FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-008FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-008FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-008FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-009FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-009FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-009FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-009FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent
69844-009FenofibratefenofibrateGraviti Pharmaceuticals Private LimitedANDACurrent