NDA 022267

ABBVIE INC

FDA Drug Application

Application #022267

Documents

• Label: 2009-10-21
• Other Important Information from FDA: 2011-12-20
• Summary Review: 2009-09-03
• Letter: 2009-11-24
• Label: 2008-03-27
• Review: 2009-09-03
• Pediatric Medical Review: 1900-01-01

Application Sponsors

NDA 022267

ABBVIE INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE; ORAL	250MG	0	DEPAKOTE ER	DIVALPROEX SODIUM
002	TABLET, EXTENDED RELEASE; ORAL	500MG	0	DEPAKOTE ER	DIVALPROEX SODIUM

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2008-03-24

PRIORITY

Submissions Property Types

ORIG

1

Null

26

CDER Filings

ABBVIE INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22267
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEPAKOTE ER","activeIngredients":"DIVALPROEX SODIUM","strength":"250MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DEPAKOTE ER","activeIngredients":"DIVALPROEX SODIUM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/15\/2009","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022267s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022267lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEPAKOTE ER","submission":"DIVALPROEX SODIUM","actionType":"250MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEPAKOTE ER","submission":"DIVALPROEX SODIUM","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-10-15
        )

)