FDA.reportPublic FDA data

Application 204604

Type
ANDA
Sponsor
AMNEAL PHARMS

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
65162-732Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-732Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-732Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-732Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-732Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-732Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-732Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent