ANDA 079163

UNICHEM LABS LTD

FDA Drug Application

Application #079163

Application Sponsors

ANDA 079163

UNICHEM LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, DELAYED RELEASE;ORAL	EQ 125MG VALPROIC ACID	0	DIVALPROEX SODIUM	DIVALPROEX SODIUM
002	TABLET, DELAYED RELEASE;ORAL	EQ 250MG VALPROIC ACID	0	DIVALPROEX SODIUM	DIVALPROEX SODIUM
003	TABLET, DELAYED RELEASE;ORAL	EQ 500MG VALPROIC ACID	0	DIVALPROEX SODIUM	DIVALPROEX SODIUM

FDA Submissions

	ORIG	1	AP	2011-04-05
LABELING; Labeling	SUPPL	3	AP	2014-02-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-02-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-11-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-01-09	STANDARD
LABELING; Labeling	SUPPL	23	AP	2022-11-03	STANDARD
LABELING; Labeling	SUPPL	28	AP	2022-11-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	11	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	20	Null	15
SUPPL	23	Null	7
SUPPL	28	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UNICHEM LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79163
            [companyName] => UNICHEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 125MG VALPROIC ACID","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 250MG VALPROIC ACID","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DIVALPROEX SODIUM","activeIngredients":"DIVALPROEX SODIUM","strength":"EQ 500MG VALPROIC ACID","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 125MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 500MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)