FDA.reportPublic FDA data

Application 071251

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENETABLET;ORAL50MG;75MGNoNo
002TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENETABLET;ORAL25MG;37.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-952Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAidarex Pharmaceuticals LLCANDACurrent
42291-842Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAvKARE, Inc.ANDACurrent
42291-842Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAvKAREANDACurrent
50090-0372Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-0372Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1271Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1271Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-1271Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
51407-286Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
51407-286Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
51655-630Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNorthwind PharmaceuticalsANDACurrent
53002-2252Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideRPK Pharmaceuticals, Inc.ANDACurrent
53808-0983Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideState of Florida DOH Central PharmacyANDACurrent
60505-2656Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideApotex Corp.ANDACurrent
60505-2656Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideApotex Corp.ANDACurrent
60505-2656Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideApotex Corp.ANDACurrent
60505-2657Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideApotex Corp.ANDACurrent
60505-2657Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideApotex Corp.ANDACurrent
60505-2657Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideApotex Corp.ANDACurrent
61919-338TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEDirectRXANDACurrent
61919-338TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEDirectRXANDACurrent
61919-338TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEDirectRXANDACurrent
61919-338TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEDirectRXANDACurrent
66267-207Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68001-327Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68001-327Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68001-327Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68001-328Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68001-328Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68001-328Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBluePoint LaboratoriesANDACurrent
68071-1819Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1819Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68084-750Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAmerican Health PackagingANDACurrent
68084-750Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAmerican Health PackagingANDACurrent
68084-750Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAmerican Health PackagingANDACurrent
68084-750Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAmerican Health PackagingANDACurrent
68788-6996Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7893Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7893Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideApotex Corp.ANDACurrent
68788-9494Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0875Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0875Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0875Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0875Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0875Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-0875Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70934-143Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0326Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0326Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0326Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0356Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0356Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0356Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71610-431Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-431Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-605Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-684Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-183Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-183Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-183Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-183Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent