MedPath

Carnitor

CARNITOR (levocarnitine) Oral Solution (1 g per 10 mL multidose)

Approved
Approval ID

b2cbc620-59fd-47b6-9e4b-7e3e31533a1c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 21, 2023

Manufacturers
FDA

Leadiant Biosciences, Inc.

DUNS: 068301431

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

levocarnitine

PRODUCT DETAILS

NDC Product Code54482-145
Application NumberNDA019257
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 21, 2023
Generic Namelevocarnitine

INGREDIENTS (6)

MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
LEVOCARNITINEActive
Quantity: 1 g in 10 mL
Code: 0G389FZZ9M
Classification: ACTIB

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Carnitor - FDA Drug Approval Details