Application 090445

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NABUMETONENABUMETONETABLET;ORAL500MGNoNo
002NABUMETONENABUMETONETABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-141NabumetonenabumetoneLupin Pharmaceuticals, Inc.ANDACurrent
68180-141NabumetonenabumetoneLupin Pharmaceuticals, Inc.ANDACurrent
68180-142NabumetonenabumetoneLupin Pharmaceuticals, Inc.ANDACurrent
68180-142NabumetonenabumetoneLupin Pharmaceuticals, Inc.ANDACurrent