FDA.reportPublic FDA data

Application 200839

Type
ANDA
Sponsor
MACLEODS PHARMS 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
10544-143LevofloxacinLevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
10544-906LevofloxacinLevofloxacinBlenheim Pharmacal, Inc.ANDACurrent
12634-674LevofloxacinLevofloxacinApotheca Inc.ANDACurrent
12634-675LevofloxacinLevofloxacinApotheca Inc.ANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-021LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-022LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-023LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-531LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-532LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
33342-533LevofloxacinLevofloxacinMacleods Pharmaceuticals LimitedANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-637LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, InANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-638LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-796LevofloxacinLevofloxacinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-4572LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4572LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4573LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4573LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4797LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50090-4797LevofloxacinLevofloxacinA-S Medication SolutionsANDACurrent
50436-0022LevofloxacinLevofloxacinUnit Dose ServicesANDACurrent
51655-249LevofloxacinLevofloxacinNorthwind PharmaceuticalsANDACurrent
51655-250LevofloxacinLevofloxacinNorthwind PharmaceuticalsANDACurrent
53002-1391LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-2582LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53002-3350LevofloxacinLevofloxacinRPK Pharmaceuticals, Inc.ANDACurrent
53217-199LevofloxacinLevofloxacinAidarex Pharmaceuticals LLCANDACurrent
54348-611LevofloxacinLEVOFLOXACINPharmPak, Inc.ANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
55700-729LevofloxacinLevofloxacinQuality Care Products, LLCANDACurrent
58118-1022LevofloxacinLevofloxacinClinical Solutions Wholesale, LLCANDACurrent
58118-1022LevofloxacinLevofloxacinClinical Solutions Wholesale, LLCANDACurrent
61919-359LEVAQUINLEVOFLOXACINDIRECT RXANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirectRXANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-704LEVOFLOXACINLEVOFLOXACINDirect_RxANDACurrent
61919-741LevofloxacinLevofloxacinDirect RxANDACurrent
63187-438LevofloxacinLevofloxacinProficient Rx LPANDACurrent