FDA.reportPublic FDA data

Application 090722

Type
ANDA
Sponsor
TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOFLOXACINLEVOFLOXACINTABLET;ORAL250MGNoNo
002LEVOFLOXACINLEVOFLOXACINTABLET;ORAL500MGNoNo
003LEVOFLOXACINLEVOFLOXACINTABLET;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13668-082LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LimitedANDACurrent
13668-082LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LANDACurrent
13668-082LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LimitedANDACurrent
13668-083LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LimitedANDACurrent
13668-083LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LANDACurrent
13668-083LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LimitedANDACurrent
13668-084LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LimitedANDACurrent
13668-084LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LANDACurrent
13668-084LEVOFLOXACINLEVOFLOXACINTorrent Pharmaceuticals LimitedANDACurrent
58517-220LEVOFLOXACINLEVOFLOXACINNew Horizon Rx Group, LLCANDACurrent
63629-4843LEVOFLOXACINLEVOFLOXACINBryant Ranch PrepackANDACurrent
63629-4843levofloxacinlevofloxacinBryant Ranch PrepackANDACurrent
68788-9695LEVOFLOXACINLEVOFLOXACINPreferred Pharmaceuticals, Inc.ANDACurrent