FDA.reportPublic FDA data

Application 201531

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTANIRBESARTANTABLET;ORAL75MGNoNo
002IRBESARTANIRBESARTANTABLET;ORAL150MGNoNo
003IRBESARTANIRBESARTANTABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-410IrbesartanIrbesartanLUPIN LIMITEDANDACurrent
57297-411IrbesartanIrbesartanLUPIN LIMITEDANDACurrent
57297-412IrbesartanIrbesartanLUPIN LIMITEDANDACurrent
68180-410IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-410IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-410IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-410IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-410IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-410IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-411IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-411IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-411IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-411IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-411IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-411IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-412IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-412IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-412IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-412IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-412IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent
68180-412IrbesartanIrbesartanLupin Pharmaceuticals, Inc.ANDACurrent