FDA.reportPublic FDA data

Application 213827

Type
ANDA
Sponsor
INNOGENIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOLAZONEMETOLAZONETABLET;ORAL2.5MGNoNo
002METOLAZONEMETOLAZONETABLET;ORAL5MGNoNo
003METOLAZONEMETOLAZONETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-431MetolazoneMetolazoneGolden State Medical Supply, Inc.ANDACurrent
51407-432MetolazoneMetolazoneGolden State Medical Supply, Inc.ANDACurrent
51407-433MetolazoneMetolazoneGolden State Medical Supply, Inc.ANDACurrent
60687-624MetolazoneMetolazoneAmerican Health PackagingANDACurrent
60687-635MetolazoneMetolazoneAmerican Health PackagingANDACurrent
69292-562MetolazoneMetolazoneAmici Pharmaceuticals LLC.ANDACurrent
69292-564MetolazoneMetolazoneAmici Pharmaceuticals LLC.ANDACurrent
69292-566MetolazoneMetolazoneAmici Pharmaceuticals LLC.ANDACurrent
71335-1944MetolazoneMetolazoneBryant Ranch PrepackANDACurrent