FDA.reportPublic FDA data

Application 209504

Type
ANDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL67MGNoNo
002FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL134MGNoNo
003FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43975-305FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-305FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-305FenofibrateFenofibrateAmerigen Pharmaceuticals Inc.ANDACurrent
43975-305FenofibrateFenofibrateAmerigen Pharmaceuticals Inc.ANDACurrent
43975-305FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-306FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-306FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-306FenofibrateFenofibrateAmerigen Pharmaceuticals Inc.ANDACurrent
43975-306FenofibrateFenofibrateAmerigen Pharmaceuticals Inc.ANDACurrent
43975-306FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-444FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-444FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
43975-444FenofibrateFenofibrateAmerigen Pharmaceuticals Inc.ANDACurrent
43975-444FenofibrateFenofibrateAmerigen Pharmaceuticals Inc.ANDACurrent
43975-444FenofibrateFenofibrateANI Pharmaceuticals, Inc.ANDACurrent
68071-2812FenofibrateFenofibrateNuCare Pharmaceuticals,Inc.ANDACurrent