FDA.reportPublic FDA data

Application 091497

Type
ANDA
Sponsor
PRINSTON INC

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
16571-500Losartan Potassiumlosartan potassiumRising Pharmaceuticals, IncANDACurrent
16571-501Losartan PotassiumLosartan potassiumRising Pharmaceuticals, IncANDACurrent
16571-502Losartan Potassiumlosartan potassiumRising Pharmaceuticals, IncANDACurrent
43547-360Losartan PotassiumLosartan PotassiumSolco Healthcare US, LLCANDACurrent
43547-360Losartan PotassiumLosartan PotassiumSolco Healthcare US, LLCANDACurrent
43547-360Losartan PotassiumLosartan PotassiumSolco Healthcare US, LLCANDACurrent
43547-361Losartan PotassiumLosartan potassiumSolco Healthcare US, LLCANDACurrent
43547-361Losartan PotassiumLosartan potassiumSolco Healthcare US, LLCANDACurrent
43547-361Losartan PotassiumLosartan potassiumSolco Healthcare US, LLCANDACurrent
43547-362Losartan PotassiumLosartan PotassiumSolco Healthcare US, LLCANDACurrent
43547-362Losartan PotassiumLosartan PotassiumSolco Healthcare US, LLCANDACurrent
43547-362Losartan PotassiumLosartan PotassiumSolco Healthcare US, LLCANDACurrent
50090-4255Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4255Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4255Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-6044Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
53002-1638Losartan PotassiumLosartan PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1638Losartan PotassiumLosartan PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1643Losartan PotassiumLosartan potassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-1643Losartan PotassiumLosartan potassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-2624Losartan PotassiumLosartan PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-2624Losartan PotassiumLosartan PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53217-337Losartan PotassiumLosartan potassiumAidarex Pharmaceuticals LLCANDACurrent
53217-369Losartan PotassiumLosartan PotassiumAidarex Pharmaceuticals LLCANDACurrent
55700-474Losartan PotassiumLosartan potassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-362Losartan PotassiumLosartan potassiumSt. Mary's Medical Park PharmacyANDACurrent
60760-645Losartan PotassiumLosartan potassiumST. MARY'S MEDICAL PARK PHARMACYANDACurrent
60760-645Losartan PotassiumLosartan potassiumST. MARY'S MEDICAL PARK PHARMACYANDACurrent
63187-808Losartan Potassiumlosartan potassiumProficient Rx LPANDACurrent
63187-808Losartan Potassiumlosartan potassiumProficient Rx LPANDACurrent
63187-808Losartan Potassiumlosartan potassiumProficient Rx LPANDACurrent
63187-830Losartan PotassiumLosartan potassiumProficient Rx LPANDACurrent
63187-830Losartan PotassiumLosartan potassiumProficient Rx LPANDACurrent
63187-830Losartan PotassiumLosartan potassiumProficient Rx LPANDACurrent
68071-1515Losartan Potassiumlosartan potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1515Losartan Potassiumlosartan potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1517Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals,iNc.ANDACurrent
68071-1517Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals,iNc.ANDACurrent
68071-1912losartan potassiumlosartan potassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2690Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2786Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3014Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3216Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3216Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3216Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3216Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3216Losartan PotassiumLosartan potassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4454Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4454Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68645-599Losartan PotassiumLosartan potassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6333Losartan Potassiumlosartan potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-6333Losartan Potassiumlosartan potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-6462Losartan Potassiumlosartan potassiumPreferred Pharmaceuticals, IncANDACurrent
68788-7386Losartan PotassiumLosartan potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7386Losartan PotassiumLosartan potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7386Losartan PotassiumLosartan potassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7470Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8186Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8189Losartan PotassiumLosartan potassiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-1795Losartan PotassiumLosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-1795Losartan PotassiumLosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-1795Losartan PotassiumLosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-1795Losartan PotassiumLosartan potassiumREMEDYREPACK INC.ANDACurrent
70518-1858Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-1858Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-3489Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70934-660Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-226Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-226Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-226Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71335-0262Losartan PotassiumLosartan potassiumBryant Ranch PrepackANDACurrent
71335-0262Losartan PotassiumLosartan potassiumBryant Ranch PrepackANDACurrent
71335-0262Losartan PotassiumLosartan potassiumBryant Ranch PrepackANDACurrent
71335-0884Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0884Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71610-207Losartan PotassiumLosartan potassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-224Losartan PotassiumLosartan PotassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-100LOSARTAN POTASSIUMLOSARTAN POTASSIUMDIRECT RXANDACurrent
72189-100LOSARTAN POTASSIUMLOSARTAN POTASSIUMDIRECT RXANDACurrent
72189-100LOSARTAN POTASSIUMLOSARTAN POTASSIUMDIRECT RXANDACurrent