FDA.reportPublic FDA data

Application 090856

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATEFENOFIBRATETABLET;ORAL48MGNoNo
002FENOFIBRATEFENOFIBRATETABLET;ORAL145MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3904FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50090-3904FenofibrateFenofibrateA-S Medication SolutionsANDACurrent
50268-310FenofibrateFenofibrateAvPAKANDACurrent
50268-310FenofibrateFenofibrateAvPAKANDACurrent
50268-311FenofibrateFenofibrateAvPAKANDACurrent
50268-311FenofibrateFenofibrateAvPAKANDACurrent
50268-338FenofibrateFenofibrateAvPAKANDACurrent
57297-360FenofibrateFenofibrateLUPIN LIMITEDANDACurrent
57297-361FenofibrateFenofibrateLUPIN LIMITEDANDACurrent
60687-618FenofibrateFenofibrateAmerican Health PackagingANDACurrent
60687-618FenofibrateFenofibrateAmerican Health PackagingANDACurrent
60687-629FenofibrateFenofibrateAmerican Health PackagingANDACurrent
60687-629FenofibrateFenofibrateAmerican Health PackagingANDACurrent
60687-629FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-635FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-635FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-635FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-635FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-636FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-636FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-636FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68084-636FenofibrateFenofibrateAmerican Health PackagingANDACurrent
68180-360FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-360FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-360FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-360FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-361FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-361FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-361FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-361FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-388FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-388FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-388FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-389FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-389FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent
68180-389FenofibrateFenofibrateLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9301ORIG2011-12-29