FDA.report

Application 091629

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

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;100MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-224Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-224Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-224Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-224Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-224Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-225Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-225Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-225Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-225Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-225Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-226Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-226Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-226Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-226Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
16714-226Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideNorthStar Rx LLCANDACurrent
43063-873Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-873Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-873Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-873Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-986Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-986Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-986Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-986Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-986Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-986Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1641Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1641Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1745Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1745Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1745Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1745Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1745Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2632Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4301Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4305Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4305Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4447Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-4447Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideA-S Medication SolutionsANDACurrent
52343-116Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideACETRIS HEALTH, LLCANDACurrent
52343-116Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideACETRIS HEALTH, LLCANDACurrent
52343-117Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideACETRIS HEALTH, LLCANDACurrent
52343-117Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideACETRIS HEALTH, LLCANDACurrent
52343-118Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideACETRIS HEALTH, LLCANDACurrent
52343-118Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideACETRIS HEALTH, LLCANDACurrent
57237-207Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-207Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-207Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-207Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-207Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-208Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-208Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-208Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-208Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-208Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-209Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-209Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-209Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-209Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
57237-209Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideRising Health, LLCANDACurrent
60760-472Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideSt. Marys Medical Park PharmacyANDACurrent
61919-732Losartan Potassium HCTZLosartan Potassium HCTZDIRECT RXANDACurrent
61919-732Losartan Potassium HCTZLosartan Potassium HCTZDIRECT RXANDACurrent
61919-797LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDIRECT RXANDACurrent
61919-797LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDIRECT RXANDACurrent
61919-797LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDELOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEDIRECT RXANDACurrent
61919-873LOSARTAN POT/HCTZLOSARTAN POT/HCTZDirect_RxANDACurrent
61919-873LOSARTAN POT/HCTZLOSARTAN POT/HCTZDirect_RxANDACurrent
63187-599Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-599Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-602Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-602Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-727Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63187-727Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideProficient Rx LPANDACurrent
63629-6845Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-6845Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8089Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8089Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8089Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63739-527Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideMcKesson Corporation dba SKY PackagingANDACurrent
63739-527Losartan Potassium and HydrochlorothiazideLosartan Potassium and HydrochlorothiazideMcKesson CorporationANDACurrent