ANDA 090028

WOCKHARDT BIO AG

FDA Drug Application

Application #090028

Application Sponsors

ANDA 090028

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

ORIG

1

AP

2010-03-03

TE Codes

001

Prescription

AA

CDER Filings

WOCKHARDT BIO AG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90028
            [companyName] => WOCKHARDT BIO AG
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)