FDA.reportPublic FDA data

Application 205107

Type
ANDA
Sponsor
AMNEAL PHARMS

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
65162-771Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-771Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-771Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-772Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-772Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent
65162-772Montelukast SodiumMontelukastAmneal Pharmaceuticals LLCANDACurrent