ANDA 090161

DR REDDYS LABS LTD

FDA Drug Application

Application #090161

Application Sponsors

ANDA 090161

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

EQ 250MG VALPROIC ACID

0

DIVALPROEX SODIUM

DIVALPROEX SODIUM

FDA Submissions

	ORIG	1	AP	2012-03-15
LABELING; Labeling	SUPPL	3	AP	2014-11-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2014-11-22	STANDARD
LABELING; Labeling	SUPPL	5	AP	2016-02-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-02-28	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-02-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-02-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-02-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2020-02-21	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-02-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	14	Null	7
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7
SUPPL	19	Null	7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90161
            [companyName] => DR REDDYS LABS LTD
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIVALPROEX SODIUM","submission":"DIVALPROEX SODIUM","actionType":"EQ 250MG VALPROIC ACID","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)