FDA.reportPublic FDA data

Application 203072

Type
ANDA
Sponsor
PRINSTON INC

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
43547-330Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-330Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-330Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-330Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-330Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-331Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-331Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-331Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-331Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-331Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-672Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideSolco Healthcare US, LLCANDACurrent
70518-1550Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1550Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1550Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-3593Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71205-063Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-063Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideProficient Rx LPANDACurrent
71335-2099Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent