ANDA 201464

PHARMADAX INC

FDA Drug Application

Application #201464

Application Sponsors

ANDA 201464

PHARMADAX INC

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

N/A; Not Applicable	ORIG	1	AP	2012-05-25
LABELING; Labeling	SUPPL	3	AP	2021-10-01	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PHARMADAX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201464
            [companyName] => PHARMADAX INC
            [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":"05\/25\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-05-25
        )

)