FDA.reportPublic FDA data

Application 204093

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 4MG BASENoNo
002MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET, CHEWABLE;ORALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-727montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-727montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-727montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-727montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-728montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-728montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-728montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
31722-728montelukast sodiummontelukast sodiumCamber Pharmaceuticals, Inc.ANDACurrent
50090-2921montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-2921montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-4705montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-4705montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
68071-2486montelukast sodiummontelukast sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7669montelukast sodiummontelukast sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7669montelukast sodiummontelukast sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7669montelukast sodiummontelukast sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7771montelukast sodiummontelukast sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7771montelukast sodiummontelukast sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7771montelukast sodiummontelukast sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2881montelukast sodiummontelukast sodiumREMEDYREPACK INC.ANDACurrent
70518-2881montelukast sodiummontelukast sodiumREMEDYREPACK INC.ANDACurrent
71335-1602montelukast sodiummontelukast sodiumBryant Ranch PrepackANDACurrent
71335-1602montelukast sodiummontelukast sodiumBryant Ranch PrepackANDACurrent
71335-1602montelukast sodiummontelukast sodiumBryant Ranch PrepackANDACurrent
72189-223MONTELUKAST SODIUMMONTELUKAST SODIUMDIRECT RXANDACurrent