FDA.reportPublic FDA data

Application 208621

Type
ANDA
Sponsor
UNICHEM LABS LTD

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
29300-221montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-221montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-221montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-221montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-221montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-221montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-222montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-222montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-222montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-222montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-222montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-222montelukast sodiummontelukast sodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
50090-5774montelukast sodiummontelukast sodiumA-S Medication SolutionsANDACurrent