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FDA NDA · NDA019368

MOCTANIN

Sponsor: ETHITEK

APPLICATION
NDA019368
TYPE
NDA
ORIGINAL APPROVAL
1985-10-29
LATEST ACTION
2002-11-12
ROUTE
PERFUSION, BILIARY
DOSAGE FORM
LIQUID
MARKETING STATUS
Discontinued

Products

MOCTANINDiscontinued
MONOCTANOIN 100% · LIQUID · PERFUSION, BILIARY

Approval history

2002-11-12Labeling · Supplement 7AP
2002-11-12Labeling · Supplement 5AP
2002-11-12Labeling · Supplement 8AP
2002-11-12Labeling · Supplement 2AP
1992-04-03Manufacturing (CMC) · Supplement 12 · priorityAP
1991-07-03Labeling · Supplement 10AP
1990-10-04Labeling · Supplement 9AP
1990-03-22Manufacturing (CMC) · Supplement 6 · priorityAP
1990-02-12Manufacturing (CMC) · Supplement 3 · priorityAP
1988-04-21Labeling · Supplement 4AP
1986-12-22Manufacturing (CMC) · Supplement 1 · priorityAP
1985-10-29Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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