Carnitor

Treats an inborn error of metabolism. NDA 20182, held by Leadiant Biosci Inc. Levocarnitine.

As of Nov 13, 2026, NDA 20182 (Carnitor), held by Leadiant Biosci Inc, was first approved by FDA on Dec 16, 1992, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 16, 1992
Review: Priority
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 15, 1999	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 16, 1992	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carnitor200MG/ML · injectable;injection	Levocarnitine	RxReference drug

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 17, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
May 29, 2015	Supplement 13Labeling · Standard review	Approved	Label Letter
Apr 15, 2002	Supplement 8Labeling · Standard review	Approved	Label Letter
May 16, 2000	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 15, 1999	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Dec 15, 1998	Supplement 5Labeling · Standard review	Approved	None posted
Dec 1, 1997	Supplement 4Manufacturing · Priority review	Approved	None posted
Jan 27, 1997	Supplement 3Manufacturing · Priority review	Approved	None posted
Aug 10, 1995	Supplement 2Manufacturing · Priority review	Approved	None posted
Aug 7, 1995	Supplement 1Labeling · Standard review	Approved	None posted
Dec 16, 1992	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 20182
Drugs@FDA: Overview at FDA
Company: Leadiant Biosciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters