ANDA 090517

ECI PHARMS LLC

FDA Drug Application

Application #090517

Application Sponsors

ANDA 090517

ECI PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

250MG/5ML

0

VALPROIC ACID

VALPROIC ACID

FDA Submissions

	ORIG	1	AP	2010-05-28
LABELING; Labeling	SUPPL	2	AP	2015-01-16

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AA

CDER Filings

PHARMA LIFE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90517
            [companyName] => PHARMA LIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROIC ACID","activeIngredients":"VALPROIC ACID","strength":"250MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VALPROIC ACID","submission":"VALPROIC ACID","actionType":"250MG\/5ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)