FDA.report

Application 074700

Type
ANDA
Sponsor
SANDOZ

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001BUMETANIDEBUMETANIDETABLET;ORAL0.5MGNoNo
002BUMETANIDEBUMETANIDETABLET;ORAL1MGNoNo
003BUMETANIDEBUMETANIDETABLET;ORAL2MGNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0128BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0128BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0128BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0129BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0129BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0129BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0130BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0130BumetanideBumetanideEon Labs, Inc.ANDACurrent
0185-0130BumetanideBumetanideEon Labs, Inc.ANDACurrent
43353-288BumetanideBumetanideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-288BumetanideBumetanideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-292BumetanideBumetanideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-6304BumetanideBumetanideA-S Medication SolutionsANDACurrent
50090-6308BumetanideBumetanideA-S Medication SolutionsANDACurrent
50436-0129BumetanideBumetanideUnit Dose ServicesANDACurrent
63629-4968BumetanideBumetanideBryant Ranch PrepackANDACurrent
63629-4968BumetanideBumetanideBryant Ranch PrepackANDACurrent
63629-4968BumetanideBumetanideBryant Ranch PrepackANDACurrent
63629-4968BumetanideBumetanideBryant Ranch PrepackANDACurrent
68071-3023BumetanideBumetanideNuCare Pharmaceuticals, Inc..ANDACurrent
68071-3023BumetanideBumetanideNuCare Pharmaceuticals, Inc..ANDACurrent
68151-1744BumetanideBumetanideCarilion Materials ManagementANDACurrent
70518-1991BumetanideBumetanideREMEDYREPACK INC.ANDACurrent