NDA 021719

EISAI INC

FDA Drug Application

Application #021719

Documents

• Letter: 2006-10-23
• Label: 2004-10-22
• Letter: 2004-10-22
• Label: 2006-10-18

Application Sponsors

NDA 021719

EISAI INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

ARICEPT

DONEPEZIL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2004-10-18

STANDARD

CDER Filings

EISAI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21719
            [companyName] => EISAI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARICEPT","activeIngredients":"DONEPEZIL HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/13\/2006","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021719s001lbl.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\\\/21719lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ARICEPT","submission":"DONEPEZIL HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2006-10-13
        )

)