FDA.reportPublic FDA data

Application 074225

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUMETANIDEBUMETANIDETABLET;ORAL0.5MGNoNo
002BUMETANIDEBUMETANIDETABLET;ORAL1MGNoNo
003BUMETANIDEBUMETANIDETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-4536BumetanideBumetanideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5534BumetanideBumetanideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8361bumetanidebumetanideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8361bumetanidebumetanideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8362bumetanidebumetanideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8362bumetanidebumetanideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
14539-700bumetanidebumetanideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-700bumetanidebumetanideHeritage Pharma Labs, IncANDACurrent
14539-701bumetanidebumetanideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-701bumetanidebumetanideHeritage Pharma Labs, IncANDACurrent
14539-702bumetanidebumetanideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
14539-702bumetanidebumetanideHeritage Pharma Labs, IncANDACurrent
33261-983BumetanideBumetanideAidarex Pharmaceuticals LLCANDACurrent
68071-2019BumetanideBumetanideNuCare Pharmaceuticals, Inc.ANDACurrent
68151-0087BumetanideBumetanideCarilion Materials ManagementANDACurrent