Application Sponsors
ANDA 203911 | SPECTRON MRC LLC | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | 4-500mCi/ML | 0 | FLUDEOXYGLUCOSE F18 | FLUDEOXYGLUCOSE F-18 |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-04-22 | |
Submissions Property Types
CDER Filings
NUKEMED
cder:Array
(
[0] => Array
(
[ApplNo] => 203911
[companyName] => NUKEMED
[docInserts] => ["",""]
[products] => [{"drugName":"FLUDEOXYGLUCOSE F18","activeIngredients":"FLUDEOXYGLUCOSE F-18","strength":"4-500mCi\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/22\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-04-22
)
)