Documents
Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Discontinued | 004 |
Application Products
001 | CAPSULE;ORAL | EQ 10MG BASE | 0 | COGNEX | TACRINE HYDROCHLORIDE |
002 | CAPSULE;ORAL | EQ 20MG BASE | 0 | COGNEX | TACRINE HYDROCHLORIDE |
003 | CAPSULE;ORAL | EQ 30MG BASE | 0 | COGNEX | TACRINE HYDROCHLORIDE |
004 | CAPSULE;ORAL | EQ 40MG BASE | 0 | COGNEX | TACRINE HYDROCHLORIDE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1993-09-09 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 1995-06-15 | PRIORITY |
LABELING; Labeling | SUPPL | 4 | AP | 1997-10-10 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-02-21 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 6 | AP | 1997-10-10 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-07-15 | PRIORITY |
LABELING; Labeling | SUPPL | 9 | AP | 1998-07-02 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-10-15 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2003-06-19 | PRIORITY |
LABELING; Labeling | SUPPL | 13 | AP | 2003-06-19 | PRIORITY |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 13 | Null | 0 |
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
)
)