APPLICATION
NDA018948
TYPE
NDA
ORIGINAL APPROVAL
1985-12-27
LATEST ACTION
2018-04-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION, TABLET
MARKETING STATUS
Discontinued, Prescription
Products
CARNITORDiscontinued
LEVOCARNITINE 1GM/10ML · SOLUTION · ORAL
CARNITOR · ReferencePrescription
LEVOCARNITINE 330MG · TABLET · ORAL
Approval history
2013-02-22Manufacturing (CMC) · Supplement 25 · priorityAP
1998-12-15Labeling · Supplement 21 · standardAP
1997-10-21Manufacturing (CMC) · Supplement 20 · priorityAP
1997-01-27Manufacturing (CMC) · Supplement 19 · priorityAP
1996-04-16Manufacturing (CMC) · Supplement 18 · priorityAP
1995-12-20Manufacturing (CMC) · Supplement 17 · priorityAP
1994-04-13Manufacturing (CMC) · Supplement 12 · priorityAP
1993-05-11Manufacturing (CMC) · Supplement 11 · priorityAP
1992-12-16Efficacy · Supplement 9AP
1992-07-22Labeling · Supplement 15AP
1992-04-14Manufacturing (CMC) · Supplement 13 · priorityAP
1992-02-21Labeling · Supplement 10AP
1989-12-07Manufacturing (CMC) · Supplement 7 · priorityAP
1989-12-07Manufacturing (CMC) · Supplement 8 · priorityAP
1989-03-22Manufacturing (CMC) · Supplement 6 · priorityAP
1988-09-16Labeling · Supplement 5AP
1988-04-27Manufacturing (CMC) · Supplement 4 · priorityAP
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.
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