FDA.reportPublic FDA data

Application 078245

Type
ANDA
Sponsor
LUPIN LTD

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
50090-4993Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4993Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5113Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5113Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5113Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5141Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5141Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
57297-215Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-216Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-217Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLUPIN LIMITEDANDACurrent
63629-6975Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-6975Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
68180-215Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-215Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-215Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-215Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-215Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-216Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-216Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-216Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-216Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-216Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-217Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-217Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-217Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-217Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-217Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68788-7758Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7758Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7758Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9461Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2564Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2564Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2564Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2578Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2578Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2578Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
72189-167LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-167LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-167LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent
72189-167LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDirect_RxANDACurrent