NDA 019794

ABBOTT

FDA Drug Application

Application #019794

Documents

• Other Important Information from FDA: 2011-12-20

Application Sponsors

NDA 019794

ABBOTT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	EQ 250MG BASE	0	DEPAKOTE CP	DIVALPROEX SODIUM
002	TABLET, DELAYED RELEASE;ORAL	EQ 500MG BASE	0	DEPAKOTE CP	DIVALPROEX SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-12-02	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19794
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEPAKOTE CP","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DEPAKOTE CP","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEPAKOTE CP","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DEPAKOTE CP","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)