Application Sponsors
ANDA 204879 | MYLAN INSTITUTIONAL | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 100MG/ML | 0 | PYRIDOXINE HYDROCHLORIDE | PYRIDOXINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-07-14 | STANDARD |
Submissions Property Types
CDER Filings
MYLAN INSTITUTIONAL
cder:Array
(
[0] => Array
(
[ApplNo] => 204879
[companyName] => MYLAN INSTITUTIONAL
[docInserts] => ["",""]
[products] => [{"drugName":"PYRIDOXINE HYDROCHLORIDE","activeIngredients":"PYRIDOXINE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-07-14
)
)