FDA.reportPublic FDA data

Application 202801

Type
ANDA
Sponsor
HETERO LABS LTD V

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
31722-721LevofloxacinLevofloxacinCamber Pharmaceuticals, Inc.ANDACurrent
31722-722LevofloxacinLevofloxacinCamber Pharmaceuticals, Inc.ANDACurrent
31722-723LevofloxacinLevofloxacinCamber Pharmaceuticals, Inc.ANDACurrent
50090-3214LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3214LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3214LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3311LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3314LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3314LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
53002-1350LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-1350LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
61919-426LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
61919-426LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
61919-426LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-833LevofloxacinLevofloxacinProficient Rx LPANDACurrent
67296-1393LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1393LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1393LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1400LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1400LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1400LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1641LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1641LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
68071-1860LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1860LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2074LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3093LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3093LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3093LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3166LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3166LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3218LevofloxacinLevofloxacinNuCare Pharmaceuticals,InANDACurrent
68071-3218LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3218LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4512LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4547LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4738LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4738LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4738LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-6938LevofloxacinLevofloxacinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7037LevofloxacinLevofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7037LevofloxacinLevofloxacinPreferred Pharmaceuticals Inc.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0587LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0719LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0968LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70934-050LevofloxacinLevofloxacinDenton Pharma, Inc.ANDACurrent
70934-050LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-050LevofloxacinLevofloxacinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10111ORIG2015-01-12