ANDA 211698

UNIV ALAHAMA BIRM

FDA Drug Application

Application #211698

Application Sponsors

ANDA 211698

UNIV ALAHAMA BIRM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

15mCi-150mCi/4ML (3.75-37.5mCi/ML)

0

AMMONIA N 13

AMMONIA N-13

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

UNIV ALAHAMA BIRM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211698
            [companyName] => UNIV ALAHAMA BIRM
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMMONIA N 13","activeIngredients":"AMMONIA N-13","strength":"15mCi-150mCi\/4ML (3.75-37.5mCi\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-03
        )

)