FDA.reportPublic FDA data

Application 203835

Type
ANDA
Sponsor
HETERO LABS LTD V

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
31722-700Losartan PotassiumLosartan PotassiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-700Losartan PotassiumLosartan PotassiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-701Losartan PotassiumLosartan PotassiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-701Losartan PotassiumLosartan PotassiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-702Losartan PotassiumLosartan PotassiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-702Losartan PotassiumLosartan PotassiumCamber Pharmaceuticals, Inc.ANDACurrent
42708-113Losartan PotassiumLosartan PotassiumQPharma IncANDACurrent
42708-113Losartan PotassiumLosartan PotassiumQPharma IncANDACurrent
42708-151Losartan PotassiumLosartan PotassiumQPharma IncANDACurrent
42708-152Losartan PotassiumLosartan PotassiumQPharma IncANDACurrent
43063-854Losartan PotassiumLosartan PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-854Losartan PotassiumLosartan PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-854Losartan PotassiumLosartan PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-854Losartan PotassiumLosartan PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-854Losartan PotassiumLosartan PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-854Losartan PotassiumLosartan PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-4489Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4489Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4489Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4645Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4645Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4645Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4712Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4712Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4712Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4910Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
50090-4914Losartan PotassiumLosartan PotassiumA-S Medication SolutionsANDACurrent
51655-828Losartan PotassiumLosartan PotassiumNorthwind PharmaceuticalsANDACurrent
53002-3638Losartan PotassiumLosartan PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-4624Losartan PotassiumLosartan PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-4643Losartan PotassiumLosartan PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
60760-786Losartan PotassiumLosartan PotassiumSt. Mary's Medical Park PharmacyANDACurrent
63187-296Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
63187-296Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
63187-296Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
63187-357Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
63187-357Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
63187-708Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
63187-708Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
63187-708Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
68071-2216Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2216Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2344Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4471Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4471Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4471Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5114Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5114Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5147Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5147Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5175Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5175Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5181Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5181Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5209Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5209Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5212Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5212Losartan PotassiumLosartan PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68645-577Losartan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-578Losartan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-579Losartan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6405Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7664Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7664Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7664Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7665Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7665Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7665Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7737Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7737Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7737Losartan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2786Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-2786Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-2786Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70934-616Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-627Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-657Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-1102Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1102Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1580Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32472ORIG2015-08-14