FDA.reportPublic FDA data

Application 090367

Type
ANDA
Sponsor
CELLTRION

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
33261-793LevofloxacinLevofloxacinAidarex Pharmaceuticals LLCANDACurrent
33261-876LevofloxacinLevofloxacinAidarex Pharmaceuticals LLCANDACurrent
33261-891LevofloxacinLevofloxacinAidarex Pharmaceuticals LLCANDACurrent
55648-544LevofloxacinLevofloxacinWockhardt LimitedANDACurrent
55648-545LevofloxacinLevofloxacinWockhardt LimitedANDACurrent
55648-547LevofloxacinLevofloxacinWockhardt LimitedANDACurrent
64679-544LevofloxacinLevofloxacinWockhardt USA LLC.ANDACurrent
64679-545LevofloxacinLevofloxacinWockhardt USA LLC.ANDACurrent
64679-547LevofloxacinLevofloxacinWockhardt USA LLC.ANDACurrent
68788-9709LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent