Application 201087

Type
ANDA
Sponsor
PAR PHARM

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
49884-172AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-172AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-172AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-172AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-172AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-172AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-173AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-173AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-173AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-173AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-173AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-173AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-174AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-174AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-174AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-174AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-174AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-174AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-175AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-175AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-175AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-175AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-175AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-175AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-185AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-185AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-185AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-185AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-185AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
49884-185AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazidePar Pharmaceutical, Inc.ANDACurrent
51407-668AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
51407-669AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
51407-670AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
51407-671AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
51407-672AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
64380-197AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-197AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-198AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-198AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-199AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-199AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-200AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-200AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-201AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent
64380-201AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEamlodipine besylate valsartan hydrochlorothiazideStrides Pharma Science LimitedANDACurrent