Cognex

NDA 20070, held by Shionogi Inc. Tacrine Hydrochloride.

As of Nov 13, 2026, NDA 20070 (Cognex), held by Shionogi Inc, was first approved by FDA on Sep 9, 1993, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 9, 1993
Review: Priority
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 10, 1997	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Review
Sep 9, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
CognexEQ 10MG BASE · capsule;oral	Tacrine Hydrochloride	Discontinued
CognexEQ 20MG BASE · capsule;oral	Tacrine Hydrochloride	Discontinued
CognexEQ 30MG BASE · capsule;oral	Tacrine Hydrochloride	Discontinued
CognexEQ 40MG BASE · capsule;oral	Tacrine Hydrochloride	Discontinued

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 19, 2003	Supplement 12Manufacturing · Priority review	Approved	Letter
Jun 19, 2003	Supplement 13Labeling · Priority review	Approved	Letter
Oct 15, 1998	Supplement 10Manufacturing · Priority review	Approved	None posted
Jul 2, 1998	Supplement 9Labeling · Priority review	Approved	None posted
Oct 10, 1997	Supplement 4Labeling · Priority review	Approved	Review
Oct 10, 1997	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Review
Jul 15, 1997	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 21, 1996	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 15, 1995	Supplement 1Labeling · Priority review	Approved	None posted
Jun 15, 1995	Supplement 3Labeling · Priority review	Approved	None posted
Sep 9, 1993	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20070
Drugs@FDA: Overview at FDA
Company: Shionogi

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters