FDA.reportPublic FDA data

Application 204290

Type
ANDA
Sponsor
UNICHEM LABS 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
29300-220montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-220montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-220montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-220montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-220montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-220montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-2480montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-2480montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-2480montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-4919montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-4919montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
50090-4919montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent
67046-468montelukast sodiummontelukast sodiumContract Pharmacy Services-PAANDACurrent
68071-2846montelukast sodiummontelukast sodiumNuCare Pharmceuticals,Inc.ANDACurrent
68071-5278montelukast sodiummontelukast sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5278montelukast sodiummontelukast sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5278montelukast sodiummontelukast sodiumNuCare Pharmaceuticals,Inc.ANDACurrent
71205-181montelukast sodiummontelukast sodiumProficient Rx LPANDACurrent
71205-181montelukast sodiummontelukast sodiumProficient Rx LPANDACurrent
71205-181montelukast sodiummontelukast sodiumProficient Rx LPANDACurrent
71205-181montelukast sodiummontelukast sodiumProficient Rx LPANDACurrent
71335-1995montelukast sodiummontelukast sodiumBryant Ranch PrepackANDACurrent