ANDA 078239

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078239

Application Sponsors

ANDA 078239

ZYDUS PHARMS USA INC

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	2009-02-27
S; Supplement	SUPPL	2	AP	2009-08-04
LABELING; Labeling	SUPPL	3	AP	2014-09-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-09-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-09-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-09-19	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-09-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-09-19	STANDARD
LABELING; Labeling	SUPPL	11	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	14	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	23	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	24	AP	2020-01-09	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	0
SUPPL	3	Null	8
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	7
SUPPL	24	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78239
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG VALPROIC ACID","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)