ANDA 204541

ESSENTIAL ISOTOPES

FDA Drug Application

Application #204541

Application Sponsors

ANDA 204541

ESSENTIAL ISOTOPES

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

10-200mCi/ML

0

SODIUM FLUORIDE F-18

SODIUM FLUORIDE F-18

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-10-29

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

ESSENTIAL ISOTOPES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204541
            [companyName] => ESSENTIAL ISOTOPES
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM FLUORIDE F-18","activeIngredients":"SODIUM FLUORIDE F-18","strength":"10-200mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-10-29
        )

)