FDA.reportPublic FDA data

Application 210138

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
0615-8270fenofibratefenofibrateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
27241-116fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
27241-116fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
27241-116fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
27241-116fenofibratefenofibrateAjanta Pharma USA Inc.ANDACurrent
27241-116fenofibratefenofibrateAjanta Pharma USA Inc.ANDACurrent
27241-116fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
27241-117fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
27241-117fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
27241-117fenofibratefenofibrateAjanta Pharma USA Inc.ANDACurrent
27241-117fenofibratefenofibrateAjanta Pharma USA Inc.ANDACurrent
27241-117fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
27241-117fenofibratefenofibrateAjanta Pharma LimitedANDACurrent
50090-5244fenofibratefenofibrateA-S Medication SolutionsANDACurrent
50090-5244fenofibratefenofibrateA-S Medication SolutionsANDACurrent
55700-876fenofibratefenofibrateQuality Care Products, LLCANDACurrent
55700-876fenofibratefenofibrateQuality Care Products, LLCANDACurrent
60760-411fenofibratefenofibrateSt. Mary's Medical Park PharmacyANDACurrent
68071-4991fenofibratefenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4991fenofibratefenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4992fenofibratefenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4992fenofibratefenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7578fenofibratefenofibratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7578fenofibratefenofibratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7578fenofibratefenofibratePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2349fenofibratefenofibrateREMEDYREPACK INC.ANDACurrent
70518-2349fenofibratefenofibrateREMEDYREPACK INC.ANDACurrent
70518-2349fenofibratefenofibrateREMEDYREPACK INC.ANDACurrent
70518-2349fenofibratefenofibrateREMEDYREPACK INC.ANDACurrent
71205-190fenofibratefenofibrateProficient Rx LPANDACurrent
71205-190fenofibratefenofibrateProficient Rx LPANDACurrent
71205-190fenofibratefenofibrateProficient Rx LPANDACurrent
71335-1286fenofibratefenofibrateBryant Ranch PrepackANDACurrent
71335-1286fenofibratefenofibrateBryant Ranch PrepackANDACurrent
72189-172FENOFIBRATEFENOFIBRATEDirect_RxANDACurrent
72189-172FENOFIBRATEFENOFIBRATEDirect_RxANDACurrent
72189-172FENOFIBRATEFENOFIBRATEDirect_RxANDACurrent