NDA 020782

ABBOTT

FDA Drug Application

Application #020782

Documents

• Label: 2003-04-04
• Review: 2006-01-03
• Letter: 2004-06-02
• Other Important Information from FDA: 2008-02-01

Application Sponsors

NDA 020782

ABBOTT

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 3; Type 3 - New Dosage Form

ORIG

1

AP

2002-12-20

STANDARD

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20782
            [companyName] => ABBOTT
            [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":"12\/20\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20782_depakote_lbl.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] => 2002-12-20
        )

)