FDA.reportPublic FDA data

Application 200797

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 5MG BASE;12.5MG;160MGNoNo
002AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 5MG BASE;25MG;160MGNoNo
003AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;12.5MG;160MGNoNo
004AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;25MG;160MGNoNo
005AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTANTABLET;ORALEQ 10MG BASE;25MG;320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57297-771Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-772Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-773Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-774Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLUPIN LIMITEDANDACurrent
57297-775Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLUPIN LIMITEDANDACurrent
68180-771Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-771Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-771Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-771Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-772Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-772Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-772Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-772Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-773Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-773Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-773Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-773Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-774Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-774Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-774Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-774Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-775Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-775Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-775Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent
68180-775Amlodipine, Valsartan and HydrochlorothiazideAmlodipine, Valsartan and HydrochlorothiazideLupin Pharmaceuticals, Inc.ANDACurrent