← FDA DRUG APPROVALS

FDA NDA · NDA020182

CARNITOR

levocarnitine

Sponsor: LEADIANT BIOSCI INC

APPLICATION
NDA020182
TYPE
NDA
ORIGINAL APPROVAL
1992-12-16
LATEST ACTION
2018-04-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CARNITOR · ReferencePrescription
LEVOCARNITINE 200MG/ML · INJECTABLE · INJECTION

Approval history

2018-04-17Labeling · Supplement 15 · standard — Label ↗AP
2015-05-29Labeling · Supplement 13 · standard — Letter ↗AP
2002-04-15Labeling · Supplement 8 · standard — Label ↗AP
2000-05-16Manufacturing (CMC) · Supplement 7 · priorityAP
1999-12-15Efficacy · Supplement 6 · standard — Label ↗AP
1998-12-15Labeling · Supplement 5 · standardAP
1997-12-01Manufacturing (CMC) · Supplement 4 · priorityAP
1997-01-27Manufacturing (CMC) · Supplement 3 · priorityAP
1995-08-10Manufacturing (CMC) · Supplement 2 · priorityAP
1995-08-07Labeling · Supplement 1 · standardAP
1992-12-16Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →