Application Sponsors
ANDA 204927 | MYLAN LABS LTD | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 20MG/ML | 0 | ETOPOSIDE | ETOPOSIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-10-31 | |
Submissions Property Types
TE Codes
CDER Filings
MYLAN LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204927
[companyName] => MYLAN LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ETOPOSIDE","activeIngredients":"ETOPOSIDE","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-10-31
)
)