ANDA 204455

SPECTRON MRC LLC

FDA Drug Application

Application #204455

Application Sponsors

ANDA 204455

SPECTRON MRC LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

30mCi-300mCi/8ML (3.75-37.5mCi/ML)

0

AMMONIA N 13

AMMONIA N-13

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-04-23

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

SPECTRON MRC LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204455
            [companyName] => SPECTRON MRC LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMMONIA N 13","activeIngredients":"AMMONIA N-13","strength":"30mCi-300mCi\/8ML (3.75-37.5mCi\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-04-23
        )

)