ANDA 090754

SUN PHARM INDS LTD

FDA Drug Application

Application #090754

Application Sponsors

ANDA 090754

SUN PHARM INDS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

500MG/5ML (100MG/ML)

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

ORIG

1

AP

2010-06-16

Submissions Property Types

ORIG

1

Null

3

TE Codes

001

Prescription

AP

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90754
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG\/5ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG\/5ML (100MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)