FDA.reportPublic FDA data

Application 202170

Type
ANDA
Sponsor
TORRENT PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FELODIPINEFELODIPINETABLET, EXTENDED RELEASE;ORAL2.5MGNoNo
002FELODIPINEFELODIPINETABLET, EXTENDED RELEASE;ORAL5MGNoNo
003FELODIPINEFELODIPINETABLET, EXTENDED RELEASE;ORAL10MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13668-132FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-132FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-132FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-132FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-132FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-133FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-133FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-133FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-133FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-133FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-134FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-134FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-134FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-134FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
13668-134FelodipineFelodipineTorrent Pharmaceuticals LimitedANDACurrent
45865-446FelodipineFelodipineMedsource PharmaceuticalsANDACurrent
63629-5418FelodipineFelodipineBryant Ranch PrepackANDACurrent