Application Sponsors
ANDA 207570 | INVAGEN PHARMS | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-09-30 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 207570
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/30\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-09-30
)
)