FDA.reportPublic FDA data

Application 079196

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUMETANIDEBUMETANIDEINJECTABLE;INJECTION0.25MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6007BumetanideBumetanideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6007BumetanideBumetanideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6008BumetanideBumetanideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6008BumetanideBumetanideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6161BumetanideBumetanideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6161BumetanideBumetanideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6162BumetanideBumetanideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6162BumetanideBumetanideHikma Pharmaceuticals USA Inc.ANDACurrent
51662-1449BUMETANIDEBUMETANIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1449BUMETANIDEBUMETANIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
72572-040BumetanideBumetanideCivica, Inc.ANDACurrent
72572-040BumetanideBumetanideCivica, Inc.ANDACurrent
72572-041BumetanideBumetanideCivica, Inc.ANDACurrent
72572-041BumetanideBumetanideCivica, Inc.ANDACurrent