FDA.reportPublic FDA data

Application 203240

Type
ANDA
Sponsor
TORRENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORAL100MGNoNo
002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATECAPSULE, EXTENDED RELEASE;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13668-290Fluvoxamine MaleateFluvoxamine MaleateTorrent Pharmaceuticals LimitedANDACurrent
13668-291Fluvoxamine MaleateFluvoxamine MaleateTorrent Pharmaceuticals LimitedANDACurrent