Levocarnitine Oral Solution

Brand(s)
Carnitor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sigma-Tau Pharmaceuticals, Inc. (2015-06-18)
Oldest Current Product
1986-04-10
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\LEVOCARNITINE
FDAOB
ORAL\SOLUTION\LEVOCARNITINE
ORAL\TABLET\LEVOCARNITINE
SPL Active
ORAL\SOLUTION\LEVOCARNITINE
SPL Moiety
ORAL\SOLUTION\LEVOCARNITINE

product(s) by strength(s)

levocarnitine 100 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1544820148CarnitorNDASigma-Tau Pharmaceuticals, Inc.1986-04-10LEVOCARNITINEORALSOLUTIONNDA019257dd904490-83f3-4cd3-bb6f-68e28509b4b6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1503830171ANDAHi-Tech Pharmacal Co., Inc.2007-10-25LEVOCARNITINEORALSOLUTIONANDA0773993563c2f5-9814-4d55-8d90-bd7d6dcff36b
2649800503ANDARising Pharmaceuticals, Inc.2004-09-20LEVOCARNITINEORALSOLUTIONANDA076851ada35959-e317-4161-ae79-3475096c679f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250743ANDARemedyrepack Inc.2013-10-08, 2013-11-29LEVOCARNITINEORALSOLUTION649800503ANDA0768511dd9f5b4-ed67-4fed-aee2-6775d760b30a, 4ffa9844-7c03-456b-9aa2-53090bedb467

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA076851LEVOCARNITINELYNE LABORATORIES INC2004-08-10ANDA076851_001Levocarnitine Oral Tablet
2ANDA077399LEVOCARNITINEHI TECH PHARMACAL CO INC2007-10-25ANDA077399_001Levocarnitine Oral Tablet
3NDA018948CARNITORSIGMA TAU PHARMACEUTICALS INC1985-12-27NDA018948_001, NDA018948_002Levocarnitine Oral Tablet
4NDA019257CARNITORSIGMA TAU PHARMACEUTICALS INC1986-04-10NDA019257_001, NDA019257_002Levocarnitine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076851_001RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalseAA2004-08-10LEVOCARNITINE
2ANDA077399_001RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalseAA2007-10-25LEVOCARNITINE
3NDA018948_001RXLEVOCARNITINE (330MG)ORALTABLETTrueAB1985-12-27CARNITOR
4NDA018948_002discontinuedLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalse1988-04-27CARNITOR
5NDA019257_001RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONTrueAA1986-04-10CARNITOR
6NDA019257_002RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalseAA2007-03-28CARNITOR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11dd9f5b4-ed67-4fed-aee2-6775d760b30a (view SPL)Levocarnitine Oral Solution USP1g/10mL(118mL multidose)prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-291521250743
23563c2f5-9814-4d55-8d90-bd7d6dcff36b (view SPL)Levocarnitine Oral Solution USP(1 g per 10 mL multidose)prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2010-08-101503830171
34ffa9844-7c03-456b-9aa2-53090bedb467 (view SPL)Levocarnitine Oral Solution USP1g/10mL(118mL multidose)prescriptionHuman PrescriptionRemedyrepack Inc.2013-10-081521250743
4ada35959-e317-4161-ae79-3475096c679f (view SPL)Levocarnitine Oral Solution USP 1g/10mL (118mL multidose)prescriptionHuman PrescriptionRising Pharmaceuticals, Inc.manufacture2014-12-304649800503
5b2cbc620-59fd-47b6-9e4b-7e3e31533a1c (view SPL)Carnitor (levocarnitine) Oral Solution (1 g per 10 mL mulitdose)prescriptionHuman PrescriptionSigma-Tau Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE2015-06-186544820145
6dd904490-83f3-4cd3-bb6f-68e28509b4b6 (view SPL)Carnitor SF (levocarnitine) Sugar-Free Oral Solution (1 g per 10 mL mulitdose)prescriptionHuman PrescriptionSigma-Tau Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE2015-06-186544820148

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