ANDA 205687

ESSENTIAL ISOTOPES

FDA Drug Application

Application #205687

Application Sponsors

ANDA 205687

ESSENTIAL ISOTOPES

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

3.75-260mCi/ML

0

AMMONIA N 13

AMMONIA N-13

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-12-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ESSENTIAL ISOTOPES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205687
            [companyName] => ESSENTIAL ISOTOPES
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMMONIA N 13","activeIngredients":"AMMONIA N-13","strength":"3.75mCi-260mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-17
        )

)