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FDA NDA · NDA018513

CHENIX

Sponsor: LEADIANT BIOSCI INC

APPLICATION
NDA018513
TYPE
NDA
ORIGINAL APPROVAL
1983-07-28
LATEST ACTION
2010-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CHENIX · ReferenceDiscontinued
CHENODIOL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2010-05-20Labeling · Supplement 12 · unknown — Letter ↗AP
1990-01-03Labeling · Supplement 11AP
1988-11-16Labeling · Supplement 10AP
1986-12-22Labeling · Supplement 9AP
1986-04-25Manufacturing (CMC) · Supplement 4 · priorityAP
1986-04-25Manufacturing (CMC) · Supplement 2 · priorityAP
1986-04-24Labeling · Supplement 8AP
1984-12-18Manufacturing (CMC) · Supplement 5 · priorityAP
1984-04-17Manufacturing (CMC) · Supplement 1 · priorityAP
1984-04-17Manufacturing (CMC) · Supplement 6 · priorityAP
1983-07-28Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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