← FDA DRUG APPROVALS

FDA NDA · NDA019257

CARNITOR SF

levocarnitine

Sponsor: LEADIANT BIOSCI INC

APPLICATION
NDA019257
TYPE
NDA
ORIGINAL APPROVAL
1986-04-10
LATEST ACTION
2018-04-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CARNITOR SF · ReferencePrescription
LEVOCARNITINE 1GM/10ML · SOLUTION · ORAL
CARNITOR · ReferencePrescription
LEVOCARNITINE 1GM/10ML · SOLUTION · ORAL

Approval history

2018-04-17Labeling · Supplement 14 · standard — Label ↗AP
2015-05-29Labeling · Supplement 12 · standard — Label ↗AP
2007-03-28Manufacturing (CMC) · Supplement 11 — Label ↗AP
2002-04-15Labeling · Supplement 10 · standard — Letter ↗AP
1998-12-15Labeling · Supplement 9 · standardAP
1997-01-27Manufacturing (CMC) · Supplement 8 · priorityAP
1995-10-17Manufacturing (CMC) · Supplement 7 · priorityAP
1995-05-12Manufacturing (CMC) · Supplement 6 · priorityAP
1990-04-25Manufacturing (CMC) · Supplement 4 · priorityAP
1989-01-12Manufacturing (CMC) · Supplement 2 · priorityAP
1988-05-11Manufacturing (CMC) · Supplement 3 · priorityAP
1986-08-29Manufacturing (CMC) · Supplement 1 · priorityAP
1986-04-10Type 3 - New Dosage Form · Original · priorityAP
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Related on SPEQ

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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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