FDA.reportPublic FDA data

Application 090351

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGNoNo
002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGNoNo
003IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL25MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0254Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0254Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0254Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0254Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0254Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0255Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0255Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0255Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0255Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0255Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideWest-Ward Pharmaceuticals Corp.ANDACurrent
70518-1386Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1386Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1386Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1386Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1780Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2013Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2013Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2013Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-1787Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1787Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent