ANDA 078182

UPSHER SMITH LABS

FDA Drug Application

Application #078182

Documents

• Letter: 2008-08-05

Application Sponsors

ANDA 078182

UPSHER SMITH LABS

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	2008-07-29
LABELING; Labeling	SUPPL	2	AP	2014-10-23
LABELING; Labeling	SUPPL	4	AP	2014-10-23	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-10-23	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2016-02-18	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-01-03	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-08-24	STANDARD
LABELING; Labeling	SUPPL	20	AP	2022-08-24	STANDARD
LABELING; Labeling	SUPPL	22	AP	2022-08-24	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	11	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	15
SUPPL	22	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78182
            [companyName] => UPSHER SMITH LABS
            [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
        )

)