APPLICATION
ANDA075567
TYPE
ANDA
ORIGINAL APPROVAL
2001-03-29
LATEST ACTION
2024-07-16
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEVOCARNITINEPrescription
LEVOCARNITINE 200MG/ML · INJECTABLE · INJECTION
Approval history
2024-07-16Labeling · Supplement 14 · standardAP
2024-07-16Labeling · Supplement 13 · standardAP
2002-09-04Manufacturing (CMC) · Supplement 2AP
2001-07-23Labeling · Supplement 1AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.