Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | 1 | ARICEPT ODT | DONEPEZIL HYDROCHLORIDE |
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG | 1 | ARICEPT ODT | DONEPEZIL HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2004-10-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2006-10-13 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2010-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-04-04 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2013-09-06 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2015-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2018-12-18 | STANDARD |
Submissions Property Types
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 7 |
CDER Filings
EISAI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 21720
[companyName] => EISAI INC
[docInserts] => ["",""]
[products] => [{"drugName":"ARICEPT ODT","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ARICEPT ODT","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"12\/18\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020690s042,021720s014,022568s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020690s039,021720s012,022568s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020690s037,021720s010,022568s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s036,021720s009,022568s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2012","submission":"SUPPL-9","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s036,021720s009,022568s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s035,021720s008,022568s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020690s035,021720s008,022568s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2010","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022568s004,020690s033,021720s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2006","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020690s026,021720s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21720lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ARICEPT ODT","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ARICEPT ODT","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-18
)
)