FDA.reportPublic FDA data

Application 203145

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;80MGNoNo
002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;160MGNoNo
003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL12.5MG;320MGNoNo
004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;160MGNoNo
005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORAL25MG;320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-074Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-074Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-074Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-074Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-075Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-075Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-075Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-075Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-076Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-076Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-076Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-076Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-077Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-077Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-077Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-077Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-078Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-078Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-078Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
33342-078Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideMacleods Pharmaceuticals LimitedANDACurrent
50090-3576Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3576Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-3576Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5345Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-5570Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-6153Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-6210Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideA-S Medication SolutionsANDACurrent
61919-790VALSARTAN/HTCZVALSARTAN/HTCZDIRECTRXANDACurrent
63629-7194Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7194Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7282Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7282Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7282Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7282Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7282Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7301Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7301Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7301Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7301Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7443Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-7443Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8142Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
68071-1882Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2059Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2118Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2142Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3077Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4068Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4096Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4096Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4096Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4184Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4184Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4184Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4184Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4388Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4432Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4467Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6793Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-6813Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0329Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0329Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0658Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0658Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0658Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1173Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-1173Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70934-265Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-265Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-594Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-595Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-960Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-258Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-258Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-258Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-258Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-327Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71205-327Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideProficient Rx LPANDACurrent
71335-0227Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0227Valsartan and HydrochlorothiazideValsartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent