FDA.reportPublic FDA data

Application 202900

Type
ANDA
Sponsor
ZYDUS PHARMS

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
16714-831bumetanidebumetanideNorthstar Rx LLCANDACurrent
16714-831bumetanidebumetanideNorthstar Rx LLCANDACurrent
16714-832bumetanidebumetanideNorthstar Rx LLCANDACurrent
16714-832bumetanidebumetanideNorthstar Rx LLCANDACurrent
16714-833bumetanidebumetanideNorthstar Rx LLCANDACurrent
16714-833bumetanidebumetanideNorthstar Rx LLCANDACurrent
50090-5123bumetanidebumetanideA-S Medication SolutionsANDACurrent
50090-5124bumetanidebumetanideA-S Medication SolutionsANDACurrent
50090-6137bumetanidebumetanideA-S Medication SolutionsANDACurrent
50090-6138bumetanidebumetanideA-S Medication SolutionsANDACurrent
50090-6139bumetanidebumetanideA-S Medication SolutionsANDACurrent
68382-525bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-525bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-525bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-526bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-526bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-526bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-527bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-527bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-527bumetanidebumetanideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1024bumetanidebumetanideCadila Healthcare LimitedANDACurrent
70771-1024bumetanidebumetanideCadila Healthcare LimitedANDACurrent
70771-1025bumetanidebumetanideCadila Healthcare LimitedANDACurrent
70771-1025bumetanidebumetanideCadila Healthcare LimitedANDACurrent
70771-1026bumetanidebumetanideCadila Healthcare LimitedANDACurrent
70771-1026bumetanidebumetanideCadila Healthcare LimitedANDACurrent
71335-1692bumetanidebumetanideBryant Ranch PrepackANDACurrent
71335-1692bumetanidebumetanideBryant Ranch PrepackANDACurrent