SHIONOGI INC FDA Approval NDA 020070

NDA 020070

SHIONOGI INC

FDA Drug Application

Application #020070

Documents

Letter2003-06-22
Letter2003-06-22
Review1997-10-10
Review1997-10-10

Application Sponsors

NDA 020070SHIONOGI INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001CAPSULE;ORALEQ 10MG BASE0COGNEXTACRINE HYDROCHLORIDE
002CAPSULE;ORALEQ 20MG BASE0COGNEXTACRINE HYDROCHLORIDE
003CAPSULE;ORALEQ 30MG BASE0COGNEXTACRINE HYDROCHLORIDE
004CAPSULE;ORALEQ 40MG BASE0COGNEXTACRINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1993-09-09PRIORITY
LABELING; LabelingSUPPL3AP1995-06-15PRIORITY
LABELING; LabelingSUPPL4AP1997-10-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1996-02-21PRIORITY
EFFICACY; EfficacySUPPL6AP1997-10-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1997-07-15PRIORITY
LABELING; LabelingSUPPL9AP1998-07-02PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-10-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2003-06-19PRIORITY
LABELING; LabelingSUPPL13AP2003-06-19PRIORITY

Submissions Property Types

ORIG1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL12Null0
SUPPL13Null0

CDER Filings

SHIONOGI INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20070
            [companyName] => SHIONOGI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COGNEX","activeIngredients":"TACRINE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COGNEX","activeIngredients":"TACRINE HYDROCHLORIDE","strength":"EQ 20MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COGNEX","activeIngredients":"TACRINE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COGNEX","activeIngredients":"TACRINE HYDROCHLORIDE","strength":"EQ 40MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COGNEX","submission":"TACRINE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COGNEX","submission":"TACRINE HYDROCHLORIDE","actionType":"EQ 20MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COGNEX","submission":"TACRINE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COGNEX","submission":"TACRINE HYDROCHLORIDE","actionType":"EQ 40MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.