ANDA 209341

UNIV SOUTHERN CA

FDA Drug Application

Application #209341

Application Sponsors

ANDA 209341

UNIV SOUTHERN CA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

20-300mCi/ML

0

FLUDEOXYGLUCOSE F18

FLUDEOXYGLUCOSE F-18

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-12-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

UNIV SOUTHERN CA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209341
            [companyName] => UNIV SOUTHERN CA
            [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":"12\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-16
        )

)