FDA.reportPublic FDA data

Application 075753

Type
ANDA
Sponsor
RHODES PHARMS

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
42858-067FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-067FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-067FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-067FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-134FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-134FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-134FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-134FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-200FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-200FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-200FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
42858-200FenofibrateFenofibrateRhodes Pharmaceuticals L.P.ANDACurrent
50090-4121FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-4121FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
51407-090FenofibrateFenofibrateGolden State Medical Supply Inc.ANDACurrent
51407-090FenofibrateFenofibrateGolden State Medical Supply, Inc.ANDACurrent
51407-090FenofibrateFenofibrateGolden State Medical SupplyANDACurrent
51407-090FenofibrateFenofibrateGolden State Medical SupplyANDACurrent
51407-090FenofibrateFenofibrateGolden State Medical Supply, Inc.ANDACurrent
51407-091FenofibrateFenofibrateGolden State Medical Supply Inc.ANDACurrent
51407-091FenofibrateFenofibrateGolden State Medical Supply, Inc.ANDACurrent
51407-091FenofibrateFenofibrateGolden State Medical SupplyANDACurrent
51407-091FenofibrateFenofibrateGolden State Medical SupplyANDACurrent
51407-091FenofibrateFenofibrateGolden State Medical Supply, Inc.ANDACurrent
51407-092FenofibrateFenofibrateGolden State Medical Supply Inc.ANDACurrent
51407-092FenofibrateFenofibrateGolden State Medical Supply, Inc.ANDACurrent
51407-092FenofibrateFenofibrateGolden State Medical SupplyANDACurrent
51407-092FenofibrateFenofibrateGolden State Medical SupplyANDACurrent
51407-092FenofibrateFenofibrateGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18422SUPPL2013-02-20
31007ORIG2003-04-10