FDA.reportPublic FDA data

Application 203630

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGNoNo
002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGNoNo
003IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL25MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64980-382Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideRising Pharmaceuticals, Inc.ANDACurrent
64980-383Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideRising Pharmaceuticals, Inc.ANDACurrent
64980-384Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideRising Pharmaceuticals, Inc.ANDACurrent
65862-629Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-629Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-629Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-629Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-629Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-629Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-630Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-630Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-630Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-630Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-630Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-630Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-631Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-631Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-631Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-631Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-631Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent
65862-631Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAurobindo Pharma LimitedANDACurrent