FDA.reportPublic FDA data

Application 209660

Type
ANDA
Sponsor
ORIT LABS LLC

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
46708-554FenofibrateFenofibrateAlembic Pharmaceuticals LimitedANDACurrent
46708-555FenofibrateFenofibrateAlembic Pharmaceuticals LimitedANDACurrent
62332-538FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-538FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-538FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-538FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-539FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-539FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-539FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-539FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-554FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-554FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-554FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-554FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-555FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-555FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-555FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
62332-555FenofibrateFenofibrateAlembic Pharmaceuticals Inc.ANDACurrent
68788-7662FenofibrateFenofibratePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7662FenofibrateFenofibratePreferred Pharmaceuticals, Inc.ANDACurrent
70934-638FenofibrateFenofibrateDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent