ANDA 204512

NCM USA BRONX LLC

FDA Drug Application

Application #204512

Application Sponsors

ANDA 204512

NCM USA BRONX LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

20-300mCi/ML

0

FLUDEOXYGLUCOSE F18

FLUDEOXYGLUCOSE F-18

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-01-07

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

NCM USA BRONX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204512
            [companyName] => NCM USA BRONX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDEOXYGLUCOSE F18","activeIngredients":"FLUDEOXYGLUCOSE F-18","strength":"20-300mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-01-07
        )

)