FDA.reportPublic FDA data

Application 078424

Type
ANDA
Sponsor
LUPIN

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
55700-434LevofloxacinLevofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
68084-481LevofloxacinLevofloxacinAmerican Health PackagingANDACurrent
68084-482LevofloxacinLevofloxacinAmerican Health PackagingANDACurrent
68084-483LevofloxacinLevofloxacinAmerican Health PackagingANDACurrent
68180-240LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-240LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-240LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-240LevofloxacinLevofloxacinLupin Pharmaceuticals, InANDACurrent
68180-240LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-240LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-241LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-241LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-241LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-241LevofloxacinLevofloxacinLupin Pharmaceuticals, InANDACurrent
68180-241LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-241LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-242LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-242LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-242LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-242LevofloxacinLevofloxacinLupin Pharmaceuticals, InANDACurrent
68180-242LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent
68180-242LevofloxacinLevofloxacinLupin Pharmaceuticals, Inc.ANDACurrent