ANDA 203920

JUBILANT DRAXIMAGE

FDA Drug Application

Application #203920

Application Sponsors

ANDA 203920

JUBILANT DRAXIMAGE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

20-300mCi/ML

0

FLUDEOXYGLUCOSE F18

FLUDEOXYGLUCOSE F-18

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-06-23
LABELING; Labeling	SUPPL	5	AP	2021-01-27	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	15

TE Codes

001

Prescription

AP

CDER Filings

JUBILANT DRAXIMAGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203920
            [companyName] => JUBILANT DRAXIMAGE
            [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":"06\/23\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/27\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-27
        )

)