FDA.reportPublic FDA data

Application 090859

Type
ANDA
Sponsor
DR REDDYS LABS SA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL43MGNoNo
002FENOFIBRATE (MICRONIZED)FENOFIBRATECAPSULE;ORAL130MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55111-349FenofibrateFenofibrateDr. Reddy's Laboratories LimitedANDACurrent
55111-395FenofibrateFenofibrateDr. Reddy's Laboratories LimitedANDACurrent