ANDA 091360

ANCHEN PHARMS

FDA Drug Application

Application #091360

Application Sponsors

ANDA 091360

ANCHEN PHARMS

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

ORIG

1

AP

2011-10-04

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ANCHEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91360
            [companyName] => ANCHEN PHARMS
            [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":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)