ANDA 078523

HIKMA FARMACEUTICA

FDA Drug Application

Application #078523

Application Sponsors

ANDA 078523

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 100MG BASE/ML

0

VALPROATE SODIUM

VALPROATE SODIUM

FDA Submissions

	ORIG	1	AP	2010-02-17
LABELING; Labeling	SUPPL	4	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	5	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2014-12-15	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-04-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-04-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-04-21	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-04-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-04-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	15
SUPPL	13	Null	15
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78523
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROATE SODIUM","activeIngredients":"VALPROATE SODIUM","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROATE SODIUM","submission":"VALPROATE SODIUM","actionType":"EQ 100MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)