Levocarnitine Injectable Solution

Brand(s)
Carnitor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sigma-Tau Pharmaceuticals, Inc. (2015-06-18)
Oldest Current Product
1992-12-16
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\LEVOCARNITINE
FDAOB
INJECTION\INJECTION\LEVOCARNITINE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\LEVOCARNITINE
INTRAVENOUS\INJECTION\LEVOCARNITINE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\LEVOCARNITINE
INTRAVENOUS\INJECTION\LEVOCARNITINE

product(s) by strength(s)

levocarnitine 200 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1544820147CarnitorNDASigma-Tau Pharmaceuticals, Inc.1992-12-16LEVOCARNITINEINTRAVENOUSINJECTION, SOLUTIONNDA020182cf801cc4-775e-433d-9d32-e5d9a98981d3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005171045ANDAAmerican Regent, Inc.2001-10-08LEVOCARNITINEINTRAVENOUSINJECTION, SOLUTIONANDA075861cc4da2c3-f939-444d-9b5b-a57b6051c190

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007030404ANDATeva Parenteral Medicines, Inc2001-06-01LEVOCARNITINEINTRAVENOUSINJECTIONANDA0758810423ba8e-6377-4a26-baf2-c2d035671eed
2007030405ANDATeva Parenteral Medicines, Inc2001-06-01LEVOCARNITINEINTRAVENOUSINJECTIONANDA0758810423ba8e-6377-4a26-baf2-c2d035671eed

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA075567LEVOCARNITINEEUROHEALTH INTERNATIONAL SARL2001-03-29ANDA075567_001
2ANDA075861LEVOCARNITINELUITPOLD PHARMACEUTICALS INC2001-06-22ANDA075861_001
3ANDA075881LEVOCARNITINETrueTEVA PHARMACEUTICALS USA2001-03-29ANDA075881_001
4NDA020182CARNITORSIGMA TAU PHARMACEUTICALS INC1992-12-16p6335369, USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
p6429230, USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
p6696493, USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
NDA020182_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA075567_001RXLEVOCARNITINE (200MG/ML)INJECTIONFalseAP2001-03-29LEVOCARNITINE
2ANDA075861_001RXLEVOCARNITINE (200MG/ML)INJECTIONFalseAP2001-06-22LEVOCARNITINE
3ANDA075881_001discontinuedLEVOCARNITINE (200MG/ML)INJECTIONFalse2001-03-29LEVOCARNITINE
4NDA020182_001RXLEVOCARNITINE (200MG/ML)INJECTIONTrueAP1992-12-16CARNITOR

patent(s)

#idexpiration dateapplication(s)
1p6335369 (view patent)2021-01-18NDA020182
2p6429230 (view patent)2021-01-18NDA020182
3p6696493 (view patent)2021-01-18NDA020182

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10423ba8e-6377-4a26-baf2-c2d035671eed (view SPL)Levocarnitine Injection, USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2012-08-083007030404, 007030405
2cc4da2c3-f939-444d-9b5b-a57b6051c190 (view SPL)LEVOCARNITINE INJECTION, USP1 g per 5 mL FOR INTRAVENOUS USE ONLYprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, MANUFACTURE, STERILIZE2014-08-044005171045
3cf801cc4-775e-433d-9d32-e5d9a98981d3 (view SPL)Carnitor (levocarnitine) Injection 1 g per 5 mL vialFor Intravenous Use OnlyprescriptionHuman PrescriptionSigma-Tau Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE2015-06-188544820147

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