Application Sponsors
ANDA 203920 | JUBILANT DRAXIMAGE | |
Marketing Status
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
TE Codes
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
)
)