FDA.reportPublic FDA data

Application 076890

Type
ANDA
Sponsor
CIPLA LTD

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
50090-2963LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-2967LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-3013LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
53217-318LevofloxacinLevofloxacinAidarex Pharmaceuticals LLCANDACurrent
55700-454LevofloxacinLevofloxacinLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-440LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
61919-440LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
61919-440LEVOFLOXACINLEVOFLOXACINDIRECT RXANDACurrent
63187-384LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-384LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-384LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-925LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63187-925LevofloxacinLevofloxacinProficient Rx LPANDACurrent
63629-7681LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
63629-7681LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
67296-1351LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1351LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1351LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1535LevofloxacinLevofloxacinRedPharm DrugANDACurrent
67296-1535LevofloxacinLevofloxacinRedPharm DrugANDACurrent
67296-1535LevofloxacinLevofloxacinRedPharm DrugANDACurrent
67296-1546LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1546LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
67296-1546LevofloxacinLevofloxacinRedPharm Drug, Inc.ANDACurrent
68071-3089LevofloxacinLevofloxacinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3091LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3271LevofloxacinLevofloxacinNuCare Pharmaceuticals ,Inc.ANDACurrent
68071-4101LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4340LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4623LevofloxacinLevofloxacinNuCare Pharmaceuticals,Inc.ANDACurrent
69097-282LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-282LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-282LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-282LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-287LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-287LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-287LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-287LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-287LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-289LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-289LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-289LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
69097-289LevofloxacinLevofloxacinCipla USA Inc.ANDACurrent
70518-0709LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-0709LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-1135LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
70518-1135LevofloxacinLevofloxacinREMEDYREPACK INC.ANDACurrent
71335-0133LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0391LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0391LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0391LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent
71335-0525LevofloxacinLevofloxacinBryant Ranch PrepackANDACurrent