FDA.reportPublic FDA data

Application 202230

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL25MGNoNo
002LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL50MGNoNo
003LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-044Losartan potassiumLosartan potassiumMacleods Pharmaceuticals LimitedANDACurrent
33342-044Losartan potassiumLosartan potassiumMacleods Pharmaceuticals LimitedANDACurrent
33342-045Losartan potassiumLosartan potassiumMacleods Pharmaceuticals LimitedANDACurrent
33342-045Losartan potassiumLosartan potassiumMacleods Pharmaceuticals LimitedANDACurrent
33342-046Losartan potassiumLosartan potassiumMacleods Pharmaceuticals LimitedANDACurrent
33342-046Losartan potassiumLosartan potassiumMacleods Pharmaceuticals LimitedANDACurrent
68071-4036Losartan potassiumLosartan potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4062Losartan potassiumLosartan potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4244Losartan potassiumLosartan potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4248Losartan potassiumLosartan potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
70934-932Losartan potassiumLosartan potassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent