FDA.report

Application 076509

Type
ANDA
Sponsor
IMPAX LABS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL54MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL160MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-5511FENOFIBRATEFENOFIBRATEImpax GenericsANDACurrent
0115-5511FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5511FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5511FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5511FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5511FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5522FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5522FENOFIBRATEFENOFIBRATEImpax GenericsANDACurrent
0115-5522FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5522FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5522FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-5522FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0179-0091FENOFIBRATEFENOFIBRATEKAISER FOUNDATION HOSPITALSANDACurrent
0179-0103FENOFIBRATEFENOFIBRATEKAISER FOUNDATION HOSPITALSANDACurrent
33261-966FENOFIBRATEFENOFIBRATEAidarex Pharmaceuticals LLCANDACurrent
35356-916FENOFIBRATEFENOFIBRATELake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-916FENOFIBRATEFENOFIBRATELake Erie Medical DBA Quality Care Products LLCANDACurrent
42291-289FENOFIBRATEFENOFIBRATEAvKARE, Inc.ANDACurrent
42291-289FENOFIBRATEFENOFIBRATEAvKARE, Inc.ANDACurrent
42291-289FENOFIBRATEFENOFIBRATEAvKAREANDACurrent
42291-289FENOFIBRATEFENOFIBRATEAvKAREANDACurrent
42291-290FENOFIBRATEFENOFIBRATEAvKARE, Inc.ANDACurrent
42291-290FENOFIBRATEFENOFIBRATEAvKARE, Inc.ANDACurrent
42291-290FENOFIBRATEFENOFIBRATEAvKAREANDACurrent
42291-290FENOFIBRATEFENOFIBRATEAvKAREANDACurrent
50090-1274FENOFIBRATEFENOFIBRATEA-S Medication SolutionsANDACurrent
50090-1274FENOFIBRATEFENOFIBRATEA-S Medication SolutionsANDACurrent
50090-1274FENOFIBRATEFENOFIBRATEA-S Medication SolutionsANDACurrent
50268-312FENOFIBRATEFENOFIBRATEAvPAKANDACurrent
50268-312FENOFIBRATEFENOFIBRATEAvPAKANDACurrent
50268-312FENOFIBRATEFENOFIBRATEAvPAKANDACurrent
50268-313FENOFIBRATEFENOFIBRATEAvPAKANDACurrent
50268-313FENOFIBRATEFENOFIBRATEAvPAKANDACurrent
50268-313FENOFIBRATEFENOFIBRATEAvPAKANDACurrent
51655-009FenofibrateFenofibrateNorthwind PharmaceuticalsANDACurrent
60219-5511FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals NY LLCANDACurrent
60219-5522FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals NY LLCANDACurrent
63629-7151FENOFIBRATEFENOFIBRATEBryant Ranch PrepackANDACurrent
63629-7151FENOFIBRATEFENOFIBRATEBryant Ranch PrepackANDACurrent
68084-328FENOFIBRATEFENOFIBRATEAmerican Health PackagingANDACurrent
68084-328FENOFIBRATEFENOFIBRATEAmerican Health PackagingANDACurrent
68084-328FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-328FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-827FENOFIBRATEFENOFIBRATEAmerican Health PackagingANDACurrent
68084-827FENOFIBRATEFENOFIBRATEAmerican Health PackagingANDACurrent
68084-827FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-827FenofibrateFenofibrateAmerican Health PackagingANDACurrent
70934-223FENOFIBRATEFENOFIBRATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-223FENOFIBRATEFENOFIBRATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-223FENOFIBRATEFENOFIBRATEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent