ANDA 209286

LUPIN LTD

FDA Drug Application

Application #209286

Application Sponsors

ANDA 209286

LUPIN LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 250MG VALPROIC ACID	0	DIVALPROEX SODIUM	DIVALPROEX SODIUM
002	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG VALPROIC ACID	0	DIVALPROEX SODIUM	DIVALPROEX SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-10-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-11-16	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-11-16	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-11-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209286
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-10-18
        )

)