FDA.reportPublic FDA data

Application 076698

Type
ANDA
Sponsor
MYLAN

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
0378-6172MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6172MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6172MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6172MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6172MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6172MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6173MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6173MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6173MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6173MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6173MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6173MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6174MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6174MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6174MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6174MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6174MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0378-6174MetolazonemetolazoneMylan Pharmaceuticals Inc.ANDACurrent
0615-7691MetolazonemetolazoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7692MetolazonemetolazoneNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-890MetolazonemetolazoneAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-931MetolazonemetolazoneAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-023MetolazonemetolazoneMylan Institutional Inc.ANDACurrent
51079-023MetolazonemetolazoneMylan Institutional Inc.ANDACurrent
51079-023MetolazonemetolazoneMylan Institutional Inc.ANDACurrent
51079-024MetolazonemetolazoneMylan Institutional Inc.ANDACurrent
51079-024MetolazonemetolazoneMylan Institutional Inc.ANDACurrent
51079-024MetolazonemetolazoneMylan Institutional Inc.ANDACurrent
68151-2939MetolazonemetolazoneCarilion Materials ManagementANDACurrent
68151-2942MetolazonemetolazoneCarilion Materials ManagementANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43097ORIG2011-02-15