FDA.reportPublic FDA data

Application 202414

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGNoNo
002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGNoNo
003IRBESARTAN; HYDROCHLOROTHIAZIDEIRBESARTAN: HYDROCHLOROTHIAZIDETABLET; ORAL300MG; 25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-057Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-057Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-057Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-057Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-057Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-057Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-058Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-058Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-058Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-058Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-058Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-058Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
63187-653Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideProficient Rx LPANDACurrent
63187-653Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideProficient Rx LPANDACurrent
63629-7468Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7468Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7468Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7468Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
68071-2123Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
70518-1330Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1330Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1331Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1331Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent