FDA.reportPublic FDA data

Application 203081

Type
ANDA
Sponsor
AUROBINDO PHARMA 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
64980-385IrbesartanIrbesartanRising Pharmaceuticals, Inc.ANDACurrent
64980-386IrbesartanIrbesartanRising Pharmaceuticals, Inc.ANDACurrent
64980-387IrbesartanIrbesartanRising Pharmaceuticals, Inc.ANDACurrent
65862-637IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-637IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-637IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-637IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-637IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-638IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-638IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-638IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-638IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-638IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-639IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-639IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-639IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-639IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent
65862-639IrbesartanIrbesartanAurobindo Pharma LimitedANDACurrent