FDA.reportPublic FDA data

Application 077424

Type
ANDA
Sponsor
SANDOZ

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
0781-5700Losartan potassiumlosartan potassiumSandoz IncANDACurrent
0781-5700Losartan potassiumlosartan potassiumSandoz IncANDACurrent
0781-5701Losartan potassiumlosartan potassiumSandoz IncANDACurrent
0781-5701Losartan potassiumlosartan potassiumSandoz IncANDACurrent
0781-5702Losartan potassiumlosartan potassiumSandoz IncANDACurrent
0781-5702Losartan potassiumlosartan potassiumSandoz IncANDACurrent
43063-477Losartan potassiumlosartan potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-477Losartan potassiumlosartan potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-477Losartan potassiumlosartan potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-483Losartan potassiumlosartan potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-483Losartan potassiumlosartan potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-483Losartan potassiumlosartan potassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
70518-0419Losartan potassiumlosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-0789Losartan potassiumlosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-0789Losartan potassiumlosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-0857Losartan potassiumlosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-0857Losartan potassiumlosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-1527Losartan potassiumlosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-1527Losartan potassiumlosartan potassiumREMEDYREPACK INC.ANDACurrent