FDA.reportPublic FDA data

Application 203438

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONTELUKAST SODIUMMONTELUKAST SODIUMGRANULE;ORALEQ 4MG BASE/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-015MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-015MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma USA Inc.ANDACurrent
27241-015MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-015MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-015MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent
27241-015MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma LimitedANDACurrent