FDA.reportPublic FDA data

Application 202910

Type
ANDA
Sponsor
HETERO LABS LTD V

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
31722-729IrbesartanIrbesartanCamber Pharmaceuticals, Inc.ANDACurrent
31722-729IrbesartanIrbesartanCamber Pharmaceuticals, Inc.ANDACurrent
31722-730IrbesartanIrbesartanCamber Pharmaceuticals, Inc.ANDACurrent
31722-730IrbesartanIrbesartanCamber Pharmaceuticals, Inc.ANDACurrent
31722-731IrbesartanIrbesartanCamber Pharmaceuticals, Inc.ANDACurrent
31722-731IrbesartanIrbesartanCamber Pharmaceuticals, Inc.ANDACurrent
50090-1284IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50090-1284IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50090-2017IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50090-2017IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50090-2017IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50090-2017IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50090-2017IrbesartanIrbesartanA-S Medication SolutionsANDACurrent
50268-440IrbesartanIrbesartanAvPAKANDACurrent
50268-441IrbesartanIrbesartanAvPAKANDACurrent
50268-441IrbesartanIrbesartanAvPAKANDACurrent
50268-442IrbesartanIrbesartanAvPAKANDACurrent
50268-442IrbesartanIrbesartanAvPAKANDACurrent
68084-217IrbesartanIrbesartanAmerican Health PackagingANDACurrent
70518-1798IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2245IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2245IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2245IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2245IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2246IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2246IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2685IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2685IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
70518-2685IrbesartanIrbesartanREMEDYREPACK INC.ANDACurrent
71205-452IrbesartanIrbesartanProficient Rx LPANDACurrent
71205-452IrbesartanIrbesartanProficient Rx LPANDACurrent
71335-1244IrbesartanIrbesartanBryant Ranch PrepackANDACurrent
71335-1244IrbesartanIrbesartanBryant Ranch PrepackANDACurrent
71335-1547IrbesartanIrbesartanBryant Ranch PrepackANDACurrent
71335-1826IrbesartanIrbesartanBryant Ranch PrepackANDACurrent
72189-201IRBESARTANIRBESARTANdirect rxANDACurrent
72189-201IRBESARTANIRBESARTANdirect rxANDACurrent
72189-201IRBESARTANIRBESARTANdirect rxANDACurrent
72189-205IRBESARTANIRBESARTANdirect rxANDACurrent
72189-205IRBESARTANIRBESARTANdirect rxANDACurrent
72189-270IRBESARTANIRBESARTANdirect rxANDACurrent