Application Sponsors
ANDA 204513 | NCM USA BRONX LLC | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | 10-200mCi/ML | 0 | SODIUM FLUORIDE F-18 | SODIUM FLUORIDE F-18 |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2014-11-28 | |
Submissions Property Types
TE Codes
CDER Filings
NCM USA BRONX LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 204513
[companyName] => NCM USA BRONX LLC
[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":"11\/28\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2014-11-28
)
)