FDA.reportPublic FDA data

Application 204901

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;50MGNoNo
002LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL12.5MG;100MGNoNo
003LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUMTABLET;ORAL25MG;100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-423Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-423Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-423Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-424Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-424Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-424Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-425Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-425Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
43547-425Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideSolco Healthcare US, LLCANDACurrent
60760-572Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideST. MARY'S MEDICAL PARK PHARMACYANDACurrent
68071-2785Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8187Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
70518-3398Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-3420Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-3420Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-3420Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-3420Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-3420Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-2127Losartan Potassium and Hydrochlorothiazidelosartan potassium and hydrochlorothiazideBryant Ranch PrepackANDACurrent
72189-325LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect RxANDACurrent
72189-325LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect RxANDACurrent
72189-326LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDElosartan potassium and hydrochlorothiazideDirect RxANDACurrent
72189-326LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDElosartan potassium and hydrochlorothiazideDirect RxANDACurrent
72189-326LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDElosartan potassium and hydrochlorothiazideDirect RxANDACurrent
72189-327LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect RxANDACurrent