ANDA 079080

ACTAVIS LABS FL INC

FDA Drug Application

Application #079080

Application Sponsors

ANDA 079080

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, DELAYED RELEASE;ORAL

EQ 500MG VALPROIC ACID

0

DIVALPROEX SODIUM

DIVALPROEX SODIUM

FDA Submissions

	ORIG	1	AP	2011-02-25
LABELING; Labeling	SUPPL	2	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-10-19	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79080
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"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 500MG VALPROIC ACID","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)