FDA.reportPublic FDA data

Application 075868

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL67MGNoNo
002FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL134MGNoNo
003FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL200MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-0511FenofibrateFENOFIBRATEImpax GenericsANDACurrent
0115-0511FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0511FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0511FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0511FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0522FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0522FenofibrateFENOFIBRATEImpax GenericsANDACurrent
0115-0522FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0522FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0522FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0533FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0533FenofibrateFENOFIBRATEImpax GenericsANDACurrent
0115-0533FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0533FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-0533FenofibrateFENOFIBRATEAmneal Pharmaceuticals of New York LLCANDACurrent
0615-7548FenofibrateFENOFIBRATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50268-309FenofibrateFENOFIBRATEAvPAKANDACurrent
50268-309FenofibrateFENOFIBRATEAvPAKANDACurrent
50268-309FenofibrateFENOFIBRATEAvPAKANDACurrent
68084-329FenofibrateFENOFIBRATEAmerican Health PackagingANDACurrent
68084-329FenofibrateFENOFIBRATEAmerican Health PackagingANDACurrent
68084-329FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-329FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-329FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-329FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-835FenofibrateFENOFIBRATEAmerican Health PackagingANDACurrent
68084-835FenofibrateFENOFIBRATEAmerican Health PackagingANDACurrent
68084-835FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-835FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-835FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-835FenofibrateFenofibrateAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8814ORIG2003-04-10