FDA.reportPublic FDA data

Application 203432

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMTABLET;ORALEQ 10MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-018MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-018MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma USA Inc.ANDACurrent
27241-018MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-018MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-018MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-018MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
63187-692MONTELUKAST SODIUMMONTELUKAST SODIUMProficient Rx LPANDACurrent
63187-692MONTELUKAST SODIUMMONTELUKAST SODIUMProficient Rx LPANDACurrent
70518-0294MONTELUKAST SODIUMMONTELUKAST SODIUMREMEDYREPACK INC.ANDACurrent