ANDA 209781

HAINAN POLY PHARM

FDA Drug Application

Application #209781

Documents

• Letter: 2018-03-28

Application Sponsors

ANDA 209781

HAINAN POLY PHARM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

500MG/5ML (100MG/ML)

0

LEVETIRACETAM

LEVETIRACETAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

HAINAN POLY PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209781
            [companyName] => HAINAN POLY PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG\/5ML (100MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/20\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209781Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-20
        )

)