FDA.reportPublic FDA data

Application 074461

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDAPAMIDEINDAPAMIDETABLET;ORAL2.5MGNoYes
002INDAPAMIDEINDAPAMIDETABLET;ORAL1.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0069IndapamideIndapamideMylan Pharmaceuticals Inc.ANDACurrent
0378-0069IndapamideIndapamideMylan Pharmaceuticals Inc.ANDACurrent
0378-0080IndapamideIndapamideMylan Pharmaceuticals Inc.ANDACurrent
0378-0080IndapamideIndapamideMylan Pharmaceuticals Inc.ANDACurrent
21695-576IndapamideIndapamideRebel Distributors CorpANDACurrent
50090-0510IndapamideIndapamideA-S Medication SolutionsANDACurrent
51079-868IndapamideIndapamideMylan Institutional Inc.ANDACurrent
51079-868IndapamideIndapamideMylan Institutional Inc.ANDACurrent
51079-868IndapamideIndapamideMylan Institutional Inc.ANDACurrent
68151-1294IndapamideIndapamideCarilion Materials ManagementANDACurrent