FDA.reportPublic FDA data

Application 210431

Type
ANDA
Sponsor
TORRENT

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
13668-531Montelukast SodiumMontelukast SodiumTorrent Pharmaceuticals LimitedANDACurrent
13668-531Montelukast SodiumMontelukast SodiumTorrent Pharmaceuticals LimitedANDACurrent
13668-531Montelukast SodiumMontelukast SodiumTorrent Pharmaceuticals LimitedANDACurrent
13668-531Montelukast SodiumMontelukast SodiumTorrent Pharmaceuticals LimitedANDACurrent
13668-531MONTELUKAST SODIUM ORALMONTELUKAST SODIUM ORALTorrent Pharmaceuticals LimitedANDACurrent
13668-531Montelukast SodiumMontelukast SodiumTorrent Pharmaceuticals LimitedANDACurrent
13668-531Montelukast SodiumMontelukast SodiumTorrent Pharmaceuticals LimitedANDACurrent
13668-531Montelukast SodiumMontelukast SodiumTorrent Pharmaceuticals LimitedANDACurrent