Application Sponsors
ANDA 208536 | MYLAN INSTITUTIONAL | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 6MG/ML | 0 | MYLERAN | BUSULFAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-11-20 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 208536
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"BUSULFAN","activeIngredients":"BUSULFAN","strength":"6MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-11-20
)
)