FDA.reportPublic FDA data

Application 077438

Type
ANDA
Sponsor
SANDOZ

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
0781-5790LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5790LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5790LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5790LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5790LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5791LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5791LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5791LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5791LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5791LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5792LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5792LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5792LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5792LevofloxacinLevofloxacinSandoz IncANDACurrent
0781-5792LevofloxacinLevofloxacinSandoz IncANDACurrent
35356-923LevofloxacinLevofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1897LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-2001LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50436-6585LevofloxacinLevofloxacinUnit Dose ServicesANDACurrent
55700-233LevofloxacinLevofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-233LevofloxacinLevofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-233LevofloxacinLevofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-003LevofloxacinLevofloxacinProficient RxANDACurrent
63187-003LevofloxacinLevofloxacinProficient RxANDACurrent
63187-004LevofloxacinLevofloxacinProficient RxANDACurrent
63187-004LevofloxacinLevofloxacinProficient RxANDACurrent
67296-0744LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0744LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-0744LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
68788-7273LevofloxacinLevofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7273LevofloxacinLevofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0450LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-1549LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-1549LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70934-738LevofloxacinLevofloxacinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0965LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0965LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0965LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent