FDA.reportPublic FDA data

Application 077369

Type
ANDA
Sponsor
TEVA

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
0093-8232Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8232Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8232Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8232Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8232Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8232Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8238Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8238Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8238Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8238Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8238Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8238Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-342Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAvKARE, Inc.ANDACurrent
42291-342Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAvKAREANDACurrent
42291-343Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAvKAREANDACurrent
42291-343Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideAvKARE, Inc.ANDACurrent
63187-981Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideProficient Rx LPANDACurrent
63187-981Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideProficient Rx LPANDACurrent
68645-405Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideLegacy Pharmaceutical PackagingANDACurrent
70518-2247Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2247Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2247Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2247Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2247Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2619Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2619Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2619Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2619Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-1097Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1097Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1097Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9039ORIG2012-04-02