Levocarnitine Oral Tablet

Brand(s)
Carnitor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sigma-Tau Pharmaceuticals, Inc. (2015-06-18)
Oldest Current Product
1985-12-27
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\LEVOCARNITINE
FDAOB
ORAL\SOLUTION\LEVOCARNITINE
ORAL\TABLET\LEVOCARNITINE
SPL Active
ORAL\TABLET\LEVOCARNITINE
SPL Moiety
ORAL\TABLET\LEVOCARNITINE

product(s) by strength(s)

levocarnitine 330 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1544820144CarnitorNDASigma-Tau Pharmaceuticals, Inc.1985-12-27LEVOCARNITINEORALTABLETNDA018948d2133bc3-9c15-48bd-8b16-b8995a6a14cd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1649800130ANDARising Pharmaceuticals, Inc.2004-09-20LEVOCARNITINEORALTABLETANDA076858479e0e78-9b6e-4991-80f3-e92386722765

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1503830172NDAHi-Tech Pharmacal Co., Inc.2005-11-01LEVOCARNITINEORALTABLET544820144NDA018948c8a590a7-628b-45c5-ac2c-24214a69eaa6

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA076851LEVOCARNITINELYNE LABORATORIES INC2004-08-10ANDA076851_001Levocarnitine Oral Solution
2ANDA076858LEVOCARNITINECOREPHARMA LLC2004-09-20ANDA076858_001
3ANDA077399LEVOCARNITINEHI TECH PHARMACAL CO INC2007-10-25ANDA077399_001Levocarnitine Oral Solution
4NDA018948CARNITORSIGMA TAU PHARMACEUTICALS INC1985-12-27NDA018948_001, NDA018948_002Levocarnitine Oral Solution
5NDA019257CARNITORSIGMA TAU PHARMACEUTICALS INC1986-04-10NDA019257_001, NDA019257_002Levocarnitine Oral Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076851_001RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalseAA2004-08-10LEVOCARNITINE
2ANDA076858_001RXLEVOCARNITINE (330MG)ORALTABLETFalseAB2004-09-20LEVOCARNITINE
3ANDA077399_001RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalseAA2007-10-25LEVOCARNITINE
4NDA018948_001RXLEVOCARNITINE (330MG)ORALTABLETTrueAB1985-12-27CARNITOR
5NDA018948_002discontinuedLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalse1988-04-27CARNITOR
6NDA019257_001RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONTrueAA1986-04-10CARNITOR
7NDA019257_002RXLEVOCARNITINE (1GM/10ML)ORALSOLUTIONFalseAA2007-03-28CARNITOR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1479e0e78-9b6e-4991-80f3-e92386722765 (view SPL)LEVOCARNITINE TABLETS, USP330 mgRx onlyprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.2015-08-036649800130
2c8a590a7-628b-45c5-ac2c-24214a69eaa6 (view SPL)Levocarnitine Tablets USP (330 mg)prescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2009-12-231503830172
3d2133bc3-9c15-48bd-8b16-b8995a6a14cd (view SPL)Carnitor (levocarnitine) Tablets (330 mg)prescriptionHuman PrescriptionSigma-Tau Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE2015-06-188544820144

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