ANDA 078919

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078919

Application Sponsors

ANDA 078919

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, DELAYED REL PELLETS;ORAL

EQ 125MG VALPROIC ACID

0

DIVALPROEX SODIUM

DIVALPROEX SODIUM

FDA Submissions

	ORIG	1	AP	2009-01-27
LABELING; Labeling	SUPPL	3	AP	2010-01-07
LABELING; Labeling	SUPPL	4	AP	2010-04-02
LABELING; Labeling	SUPPL	7	AP	2014-02-11	STANDARD
LABELING; Labeling	SUPPL	8	AP	2014-02-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-02-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	2014-11-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	2014-11-08	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	13	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	16	AP	2015-11-30	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	20	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	2020-07-06	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-07-06	STANDARD

Submissions Property Types

SUPPL	3	Null	7
SUPPL	7	Null	8
SUPPL	8	Null	15
SUPPL	9	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	7
SUPPL	25	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78919
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 125MG VALPROIC ACID","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 125MG VALPROIC ACID","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)