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FDA NDA · NDA020070

COGNEX

Sponsor: SHIONOGI INC

APPLICATION
NDA020070
TYPE
NDA
ORIGINAL APPROVAL
1993-09-09
LATEST ACTION
2003-06-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

COGNEXDiscontinued
TACRINE HYDROCHLORIDE EQ 30MG BASE · CAPSULE · ORAL
COGNEXDiscontinued
TACRINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
COGNEXDiscontinued
TACRINE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
COGNEXDiscontinued
TACRINE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL

Approval history

2003-06-19Labeling · Supplement 13 · priority — Letter ↗AP
2003-06-19Manufacturing (CMC) · Supplement 12 · priority — Letter ↗AP
1998-10-15Manufacturing (CMC) · Supplement 10 · priorityAP
1998-07-02Labeling · Supplement 9 · priorityAP
1997-10-10Efficacy · Supplement 6 · priority — Review ↗AP
1997-10-10Labeling · Supplement 4 · priority — Review ↗AP
1997-07-15Manufacturing (CMC) · Supplement 8 · priorityAP
1996-02-21Manufacturing (CMC) · Supplement 5 · priorityAP
1995-06-15Labeling · Supplement 3 · priorityAP
1995-06-15Labeling · Supplement 1 · priorityAP
1993-09-09Type 1 - New Molecular Entity · Original · priorityAP
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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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