FDA.reportPublic FDA data

Application 091617

Type
ANDA
Sponsor
ALEMBIC PHARMS 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
46708-448Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-448Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-449Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-449Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-450Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
46708-450Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals LimitedANDACurrent
50090-3135Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3135Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4274Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4274Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
62332-048Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-048Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-048Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-048Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-048Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-048Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-049Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-049Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-049Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-049Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-049Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-049Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-050Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-050Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-050Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-050Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-050Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
62332-050Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideAlembic Pharmaceuticals Inc.ANDACurrent
63187-394Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-394Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-918Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-918Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
68071-4159Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4159Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4159Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4187Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4222Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceutiacals,Inc.ANDACurrent
68071-4222Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceutiacals,Inc.ANDACurrent
68071-4222Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceutiacals,IANDACurrent
68071-4768Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4768Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0786Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0786Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0786Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0786Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1943Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1943Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-1025Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1025Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent