levoleucovorin Injection

Brand(s)
Fusilev
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Spectrum Pharmaceuticals, Inc. (2011-04-30)
Oldest Current Product
2008-08-15
License(s)
NDA, ANDA
RxNORM
INJECTION\LEVOLEUCOVORIN
FDAOB
IV (INFUSION)\POWDER\LEVOLEUCOVORIN CALCIUM\rdfq
IV (INFUSION)\SOLUTION\LEVOLEUCOVORIN CALCIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\LEVOLEUCOVORIN CALCIUM
INTRAVENOUS\INJECTION, SOLUTION\LEVOLEUCOVORIN CALCIUM
INTRAVENOUS\INJECTION, SOLUTION\LEVOLEUCOVORIN CALCIUM PENTAHYDRATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\LEVOLEUCOVORIN
INTRAVENOUS\INJECTION, SOLUTION\LEVOLEUCOVORIN

product(s) by strength(s)

levoleucovorin 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681520102FusilevNDASpectrum Pharmaceuticals, Inc.2011-09-15LEVOLEUCOVORIN CALCIUMINTRAVENOUSINJECTION, SOLUTIONNDA02014049be5b16-dab5-4a95-b202-bfb13d730d83

17.5 ml levoleucovorin 10 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813201ANDASandoz Inc2015-04-13LEVOLEUCOVORIN CALCIUM PENTAHYDRATEINTRAVENOUSINJECTION, SOLUTIONANDA203563f977c9bb-bef1-4746-9894-4c29a1fdb0d8
2674570600ANDAMylan Institutional Llc2015-10-21LEVOLEUCOVORIN CALCIUMINTRAVENOUSINJECTION, SOLUTIONANDA20357699bd0199-f866-4bc4-9021-247927a694f2

25 ml levoleucovorin 10 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570601ANDAMylan Institutional Llc2015-10-21LEVOLEUCOVORIN CALCIUMINTRAVENOUSINJECTION, SOLUTIONANDA20357699bd0199-f866-4bc4-9021-247927a694f2

levoleucovorin 50 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681520101FusilevNDASpectrum Pharmaceuticals, Inc.2008-08-15LEVOLEUCOVORIN CALCIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA02014049be5b16-dab5-4a95-b202-bfb13d730d83

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA203563LEVOLEUCOVORIN CALCIUMSANDOZ INC2015-03-09PATENT CHALLENGE [2015-10-20]ANDA203563_001, ANDA203563_002
2ANDA203576LEVOLEUCOVORIN CALCIUMMYLAN TEORANTA2015-10-20ANDA203576_001, ANDA203576_002
3NDA020140FUSILEVSPECTRUM PHARMACEUTICALS INC2008-03-07p6500829, SUBSTANCEORPHAN DRUG EXCLUSIVITY [2015-03-07]
ORPHAN DRUG EXCLUSIVITY [2018-04-29]
NDA020140_001, NDA020140_002, NDA020140_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA203563_001RXLEVOLEUCOVORIN CALCIUM (EQ 175MG BASE/17.5ML)SOLUTIONFalseAP2015-03-09LEVOLEUCOVORIN CALCIUM
2ANDA203563_002RXLEVOLEUCOVORIN CALCIUM (EQ 250MG BASE/25ML)SOLUTIONTrueAP2015-03-09LEVOLEUCOVORIN CALCIUM
3ANDA203576_001RXLEVOLEUCOVORIN CALCIUM (EQ 175MG BASE/17.5ML)SOLUTIONFalseAP2015-10-20LEVOLEUCOVORIN CALCIUM
4ANDA203576_002RXLEVOLEUCOVORIN CALCIUM (EQ 250MG BASE/25ML)SOLUTIONFalseAP2015-10-20LEVOLEUCOVORIN CALCIUM
5NDA020140_001RXLEVOLEUCOVORIN CALCIUM (EQ 50MG BASE/VIAL)POWDERTrue2008-03-07FUSILEV
6NDA020140_002discontinuedLEVOLEUCOVORIN CALCIUM (EQ 175MG BASE/17.5ML)SOLUTIONFalse2011-04-29FUSILEV
7NDA020140_003discontinuedLEVOLEUCOVORIN CALCIUM (EQ 250MG BASE/25ML)SOLUTIONFalse2011-04-29FUSILEV

patent(s)

#idexpiration dateapplication(s)
1p6500829 (view patent)2022-03-07NDA020140

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
149be5b16-dab5-4a95-b202-bfb13d730d83 (view SPL)These highlights do not include all the information needed to use Fusilev safely and effectively. See full prescribing information for Fusilev. Fusilev (levoleucovorin) FOR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION for INTRAVENOUS use Fusilev (levoleucovorin) INJECTION, SOLUTION for INTRAVENOUS useInitial U.S. Approval: 1952 (d,l-leucovorin), 2008 (levoleucovorin)prescriptionHuman PrescriptionSpectrum Pharmaceuticals, Inc.2011-04-306681520101, 681520102
299bd0199-f866-4bc4-9021-247927a694f2 (view SPL)These highlights do not include all the information needed to use LEVOLEUCOVORIN INJECTION safely and effectively. See full prescribing information for LEVOLEUCOVORIN INJECTION. LEVOLEUCOVORIN injection, solution for intravenous use Initial U.S. Approval: 2008 (levoleucovorin)prescriptionHuman PrescriptionMylan Institutional Llc2015-06-291674570600, 674570601
3f977c9bb-bef1-4746-9894-4c29a1fdb0d8 (view SPL)These highlights do not include all the information needed to use levoleucovorin injection safely and effectively. See full prescribing information for levoleucovorin injection. LEVOLEUCOVORIN injection, solution for intravenous use Initial U.S. Approval: 2008 (levoleucovorin)prescriptionHuman PrescriptionSandoz Inc2015-03-103007813201

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