ANDA 204754

ECI PHARMS LLC

FDA Drug Application

Application #204754

Application Sponsors

ANDA 204754

ECI PHARMS LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	500MG	0	LEVETIRACETAM	LEVETIRACETAM
002	TABLET, EXTENDED RELEASE;ORAL	750MG	0	LEVETIRACETAM	LEVETIRACETAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-08-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PHARMA LIFE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204754
            [companyName] => PHARMA LIFE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-08-26
        )

)