FDA.reportPublic FDA data

Application 078232

Type
ANDA
Sponsor
LUPIN 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
50090-3231Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-3403Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-5480Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-5480Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-5481Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-5626Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
68180-210Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-210Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-376Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-376Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-376Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-376Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-376Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-377Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-377Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-377Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-377Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-377Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-378Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-378Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-378Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-378Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-378Losartan PotassiumLosartan PotassiumLupin Pharmaceuticals, Inc.ANDACurrent
68645-524Losartan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-525Losartan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-526Losartan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-7914Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7914Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-3282Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-3282Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent