FDA.reportPublic FDA data

Application 213457

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RUFINAMIDERUFINAMIDESUSPENSION;ORAL40MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-797BanzelRufinamide Oral SuspensionLupin Pharmaceuticals, Inc.ANDACurrent
68180-797RufinamideRufinamideLupin Pharmaceuticals, Inc.ANDACurrent