FDA.reportPublic FDA data

Application 216216

Type
ANDA
Sponsor
AACE PHARMS

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
10135-765METOLAZONEmetolazoneMarlex Pharmaceuticals, Inc.ANDACurrent
10135-766METOLAZONEmetolazoneMarlex Pharmaceuticals, Inc.ANDACurrent
10135-767METOLAZONEmetolazoneMarlex Pharmaceuticals, Inc.ANDACurrent
71406-113METOLAZONEmetolazoneAACE Pharmaceuticals, Inc.ANDACurrent
71406-113METOLAZONEmetolazoneAACE Pharmaceuticals, Inc.ANDACurrent
71406-114METOLAZONEmetolazoneAACE Pharmaceuticals, Inc.ANDACurrent
71406-114METOLAZONEmetolazoneAACE Pharmaceuticals, Inc.ANDACurrent
71406-115METOLAZONEmetolazoneAACE Pharmaceuticals, Inc.ANDACurrent
71406-115METOLAZONEmetolazoneAACE Pharmaceuticals, Inc.ANDACurrent