ANDA 078791

IMPAX LABS

FDA Drug Application

Application #078791

Application Sponsors

ANDA 078791

IMPAX LABS

Marketing Status

• Prescription: 001
• Prescription: 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

	ORIG	1	AP	2009-05-06
LABELING; Labeling	SUPPL	2	AP	2009-08-04
LABELING; Labeling	SUPPL	9	AP	2016-02-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-01-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-01-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-01-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-01-21	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-01-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	7
SUPPL	9	Null	15
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	20	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78791
            [companyName] => IMPAX LABS
            [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":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)