ANDA 212688

OVERSEAS

FDA Drug Application

Application #212688

Application Sponsors

ANDA 212688

OVERSEAS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

750MG

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-06-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-07-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

OVERSEAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212688
            [companyName] => OVERSEAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-11
        )

)