Levofloxacin Injection

Brand(s)
Levaquin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Claris Lifesciences Inc. (2015-07-02)
Oldest Current Product
1996-12-20
License(s)
NDA, ANDA
RxNORM
INJECTION\LEVOFLOXACIN
FDAOB
INJECTION\INJECTION\LEVOFLOXACIN\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\LEVOFLOXACIN
INTRAVENOUS\INJECTION, SOLUTION\LEVOFLOXACIN
INTRAVENOUS\INJECTION\LEVOFLOXACIN
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\LEVOFLOXACIN ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\LEVOFLOXACIN ANHYDROUS
INTRAVENOUS\INJECTION\LEVOFLOXACIN ANHYDROUS

product(s) by strength(s)

levofloxacin 25 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550201ANDAHeritage Pharmaceuticals Inc.2013-02-04LEVOFLOXACININTRAVENOUSINJECTIONANDA202590548f09a4-011c-41cc-ba21-e7d69e7113d4
2250210130ANDASagent Pharmaceuticals2012-01-05LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA200560dd902513-1411-4746-8f45-f7f3fb68f130

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780107ANDAAkorn2011-07-01LEVOFLOXACININTRAVENOUSINJECTIONANDA0916444438fed2-7ef5-488f-baa8-39bc65768d1d

30 ml levofloxacin 25 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1551500157ANDAAuromedics Pharma Llc2013-01-24LEVOFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA2023284d400bf9-988f-42ec-93f1-e71a93a324b2

20 ml levofloxacin 25 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1360000045ANDAClaris Lifesciences Inc.2013-07-01LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA09143670c87464-1806-480a-8ebd-3f02987ff436
2551500156ANDAAuromedics Pharma Llc2013-01-24LEVOFLOXACININTRAVENOUSINJECTION, SOLUTION, CONCENTRATEANDA2023284d400bf9-988f-42ec-93f1-e71a93a324b2

levofloxacin 5 mg/ml injection

original product(s)(s)

#idlabeleractive ingredient(s)routedose formspl
1633230355App Pharmaceuticals, LlcLEVOFLOXACININTRAVENOUSINJECTIONeb30fafa-bbb9-458f-89df-ae610fa6aa96

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004090528ANDAHospira, Inc.2015-09-03LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA07857917bcb105-91ff-4240-bba4-29d80001bbe4
2250210132ANDASagent Pharmaceuticals2011-06-20, 2013-07-15LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA090343699fbdb8-a6fd-476a-9b80-08197d869534, ecdf16d6-d9ae-46f3-ac64-752620017c29
3250210825ANDASagent Pharmaceuticals2011-12-05LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA090343eb5c26fc-4201-4b1a-a359-bc9bb3985522

50 ml levofloxacin 5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580167LevaquinNDAJanssen Pharmaceuticals, Inc.1996-12-20LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONNDA020635a1f01e8e-97e9-11de-b91d-553856d89593

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439722ANDAWest-Ward Pharmaceutical Corp2011-09-16LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA091375e680c759-16c5-4532-9c9c-f42c8c3df74a
2007813341ANDASandoz Inc2011-07-07LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA090343ac092092-678f-42fb-a34c-2128ebafe4b8
3360000046ANDAClaris Lifesciences Inc.2013-07-01LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA09139770c87464-1806-480a-8ebd-3f02987ff436

150 ml levofloxacin 5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580166LevaquinNDAJanssen Pharmaceuticals, Inc.1996-12-20LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONNDA020635a1f01e8e-97e9-11de-b91d-553856d89593

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439720ANDAWest-Ward Pharmaceutical Corp2011-09-16LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA091375e680c759-16c5-4532-9c9c-f42c8c3df74a
2007813343ANDASandoz Inc2011-07-07LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA090343ac092092-678f-42fb-a34c-2128ebafe4b8
3360000048ANDAClaris Lifesciences Inc.2013-07-01LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA09139770c87464-1806-480a-8ebd-3f02987ff436

100 ml levofloxacin 5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580168LevaquinNDAJanssen Pharmaceuticals, Inc.1996-12-20LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONNDA020635a1f01e8e-97e9-11de-b91d-553856d89593

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001439721ANDAWest-Ward Pharmaceutical Corp2011-09-16LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA091375e680c759-16c5-4532-9c9c-f42c8c3df74a
2007813342ANDASandoz Inc2011-07-07LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA090343ac092092-678f-42fb-a34c-2128ebafe4b8
3360000047ANDAClaris Lifesciences Inc.2013-07-01LEVOFLOXACININTRAVENOUSINJECTION, SOLUTIONANDA09139770c87464-1806-480a-8ebd-3f02987ff436

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA078577LEVOFLOXACINHOSPIRA INC2015-08-12ANDA078577_001, ANDA078577_002
2ANDA078579LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERHOSPIRA INC2015-09-03ANDA078579_001, ANDA078579_002, ANDA078579_003
3ANDA090343LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERACS DOBFAR INFO SA2011-07-07ANDA090343_001, ANDA090343_002, ANDA090343_003
4ANDA091375LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERHIKMA FARMACEUTICA (PORTUGAL) SA2011-09-16ANDA091375_001, ANDA091375_002, ANDA091375_003
5ANDA091397LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERCLARIS PHARMASERVICES2013-08-08ANDA091397_001, ANDA091397_002, ANDA091397_003
6ANDA091436LEVOFLOXACINCLARIS PHARMASERVICES2013-06-05ANDA091436_001
7ANDA091644LEVOFLOXACINTrueAKORN INC2011-06-20ANDA091644_001, ANDA091644_002
8ANDA200560LEVOFLOXACINSAGENT PHARMACEUTICALS INC2011-06-20ANDA200560_001, ANDA200560_002
9ANDA200674LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERFRESENIUS KABI USA LLC2013-06-19ANDA200674_001, ANDA200674_002, ANDA200674_003
10ANDA202328LEVOFLOXACINAUROBINDO PHARMA LTD2013-01-24ANDA202328_001, ANDA202328_002
11ANDA202590LEVOFLOXACINEMCURE PHARMACEUTICALS LTD2013-01-24ANDA202590_001, ANDA202590_002
12NDA020635LEVAQUINJANSSEN PHARMACEUTICALS INC1996-12-20NDA020635_001, NDA020635_002, NDA020635_003, NDA020635_004, NDA020635_005

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078577_001RXLEVOFLOXACIN (EQ 500MG/20ML)INJECTIONFalseAP2015-08-12LEVOFLOXACIN
2ANDA078577_002RXLEVOFLOXACIN (EQ 750MG/30ML)INJECTIONFalseAP2015-08-12LEVOFLOXACIN
3ANDA078579_001RXLEVOFLOXACIN (EQ 250MG/50ML)INJECTIONFalseAP2015-09-03LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
4ANDA078579_002RXLEVOFLOXACIN (EQ 500MG/100ML)INJECTIONFalseAP2015-09-03LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
5ANDA078579_003RXLEVOFLOXACIN (EQ 750MG/150ML)INJECTIONFalseAP2015-09-03LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
6ANDA090343_001RXLEVOFLOXACIN (EQ 250MG/50ML)INJECTIONFalseAP2011-07-07LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
7ANDA090343_002RXLEVOFLOXACIN (EQ 500MG/100ML)INJECTIONFalseAP2011-07-07LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
8ANDA090343_003RXLEVOFLOXACIN (EQ 750MG/150ML)INJECTIONFalseAP2011-07-07LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
9ANDA091375_001RXLEVOFLOXACIN (EQ 250MG/50ML)INJECTIONFalseAP2011-09-16LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
10ANDA091375_002RXLEVOFLOXACIN (EQ 500MG/100ML)INJECTIONFalseAP2011-09-16LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
11ANDA091375_003RXLEVOFLOXACIN (EQ 750MG/150ML)INJECTIONFalseAP2011-09-16LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
12ANDA091397_001RXLEVOFLOXACIN (EQ 250MG/50ML)INJECTIONFalseAP2013-08-08LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
13ANDA091397_002RXLEVOFLOXACIN (EQ 500MG/100ML)INJECTIONFalseAP2013-08-08LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
14ANDA091397_003RXLEVOFLOXACIN (EQ 750MG/150ML)INJECTIONFalseAP2013-08-08LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
15ANDA091436_001RXLEVOFLOXACIN (EQ 500MG/20ML)INJECTIONFalseAP2013-06-05LEVOFLOXACIN
16ANDA091644_001discontinuedLEVOFLOXACIN (EQ 500MG/20ML)INJECTIONFalse2011-06-20LEVOFLOXACIN
17ANDA091644_002discontinuedLEVOFLOXACIN (EQ 750MG/30ML)INJECTIONFalse2011-06-20LEVOFLOXACIN
18ANDA200560_001RXLEVOFLOXACIN (EQ 500MG/20ML)INJECTIONFalseAP2011-06-20LEVOFLOXACIN
19ANDA200560_002RXLEVOFLOXACIN (EQ 750MG/30ML)INJECTIONFalseAP2011-06-20LEVOFLOXACIN
20ANDA200674_001RXLEVOFLOXACIN (EQ 250MG/50ML)INJECTIONFalseAP2013-06-19LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
21ANDA200674_002RXLEVOFLOXACIN (EQ 500MG/100ML)INJECTIONFalseAP2013-06-19LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
22ANDA200674_003RXLEVOFLOXACIN (EQ 750MG/150ML)INJECTIONFalseAP2013-06-19LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
23ANDA202328_001RXLEVOFLOXACIN (EQ 500MG/20ML)INJECTIONFalseAP2013-01-24LEVOFLOXACIN
24ANDA202328_002RXLEVOFLOXACIN (EQ 750MG/30ML)INJECTIONFalseAP2013-01-24LEVOFLOXACIN
25ANDA202590_001RXLEVOFLOXACIN (EQ 500MG/20ML)INJECTIONFalseAP2013-01-24LEVOFLOXACIN
26ANDA202590_002RXLEVOFLOXACIN (EQ 750MG/30ML)INJECTIONFalseAP2013-01-24LEVOFLOXACIN
27NDA020635_001RXLEVOFLOXACIN (EQ 500MG/20ML)INJECTIONTrueAP1996-12-20LEVAQUIN
28NDA020635_002RXLEVOFLOXACIN (EQ 250MG/50ML)INJECTIONTrueAP1996-12-20LEVAQUIN
29NDA020635_003RXLEVOFLOXACIN (EQ 500MG/100ML)INJECTIONTrueAP1996-12-20LEVAQUIN
30NDA020635_004RXLEVOFLOXACIN (EQ 750MG/30ML)INJECTIONTrueAP1996-12-20LEVAQUIN
31NDA020635_005RXLEVOFLOXACIN (EQ 750MG/150ML)INJECTIONTrueAP1996-12-20LEVAQUIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
117bcb105-91ff-4240-bba4-29d80001bbe4 (view SPL)These highlights do not include all the information needed to use Levofloxacin in 5% Dextrose Injection safely and effectively. See full prescribing information for Levofloxacin in 5% Dextrose Injection.Levofloxacin in 5% Dextrose Injection, Solution for Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2015-05-311004090528
24438fed2-7ef5-488f-baa8-39bc65768d1d (view SPL)These highlights do not include all the information needed to use Levofloxacin Injection safely and effectively. See full prescribing information for Levofloxacin Injection.Levofloxacin InjectionIntravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-08-115174780107
34d400bf9-988f-42ec-93f1-e71a93a324b2 (view SPL)These highlights do not include all the information needed to use levofloxacin injection safely and effectively. See full prescribing information for levofloxacin injection. LEVOFLOXACIN INJECTION, Solution, Concentrate for Intravenous useInitial U.S. Approval: 1996prescriptionHuman PrescriptionAuromedics Pharma LlcANALYSIS, API MANUFACTURE, MANUFACTURE2014-07-316551500156, 551500157
4548f09a4-011c-41cc-ba21-e7d69e7113d4 (view SPL)These highlights do not include all the information needed to use Levofloxacin injection safely and effectively. See full prescribing information for Levofloxacin injection.Initial U.S. Approval: 1996To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.prescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-06-216231550201
5699fbdb8-a6fd-476a-9b80-08197d869534 (view SPL)These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin.LEVOFLOXACIN INJECTION in 5% dextrose, for Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2015-01-1212250210132
670c87464-1806-480a-8ebd-3f02987ff436 (view SPL)These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for Levofloxacin Injection, 25 mg/mL and Levofloxacin Injection in 5% Dextrose, 5 mg/mL.Initial U.S. Approval: 1996prescriptionHuman PrescriptionClaris Lifesciences Inc.MANUFACTURE2015-07-029360000045, 360000046, 360000047, 360000048
7a1f01e8e-97e9-11de-b91d-553856d89593 (view SPL)These highlights do not include all the information needed to use LEVAQUIN safely and effectively. See full prescribing information for LEVAQUIN. LEVAQUIN (levofloxacin) Tablet, Film Coated for Oral use LEVAQUIN (levofloxacin) Solution for Oral use LEVAQUIN (levofloxacin) Injection, Solution for Intravenous use Initial U.S. Approval: 1996prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-07-0814504580166, 504580167, 504580168, 504580170, 504580920, 504580925, 504580930Levofloxacin Oral Solution
Levofloxacin Oral Tablet
8ac092092-678f-42fb-a34c-2128ebafe4b8 (view SPL)These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. LEVOFLOXACIN INJECTION in 5% dextrose, for Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionSandoz Inc2015-04-3012007813341, 007813342, 007813343
9dd902513-1411-4746-8f45-f7f3fb68f130 (view SPL)These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. Levofloxacin Injection, for IV UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2013-10-318250210130
10e680c759-16c5-4532-9c9c-f42c8c3df74a (view SPL)These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. LEVOFLOXACIN INJECTION in 5% Dextrose, Solution for Intravenous Use Initial U.S. Approval: 1996prescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpANALYSIS, LABEL, MANUFACTURE, PACK2014-10-074001439720, 001439721, 001439722
11eb30fafa-bbb9-458f-89df-ae610fa6aa96 (view SPL)These highlights do not include all the information needed to use LEVOFLOXACIN IN 5% DEXTROSE INJECTION safely and effectively. See full prescribing information for LEVOFLOXACIN IN 5% DEXTROSE INJECTION. LEVOFLOXACIN IN 5% DEXTROSE INJECTION, Solution for Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-03-073633230355
12eb5c26fc-4201-4b1a-a359-bc9bb3985522 (view SPL)These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. LEVOFLOXACIN INJECTION in 5% dextrose, for Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2015-01-137250210825
13ecdf16d6-d9ae-46f3-ac64-752620017c29 (view SPL)These highlights do not include all the information needed to use levofloxacin safely and effectively. See full prescribing information for levofloxacin. LEVOFLOXACIN INJECTION in 5% dextrose, for Intravenous UseInitial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2015-02-174250210132

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII