Application Sponsors
ANDA 203554 | MYLAN INSTITUTIONAL | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 10MG/VIAL | 0 | PENTOSTATIN | PENTOSTATIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2014-09-19 | |
Submissions Property Types
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 203554
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"PENTOSTATIN","activeIngredients":"PENTOSTATIN","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/19\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2014-09-19
)
)