Application Sponsors
ANDA 208200 | INVAGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 10MG | 0 | VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE |
002 | TABLET;ORAL | 40MG | 0 | VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE |
003 | TABLET;ORAL | 20MG | 0 | VILAZODONE HYDROCHLORIDE | VILAZODONE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-04-07 | STANDARD |
UNKNOWN; | ORIG | 2 | TA | 2021-04-07 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 208200
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/07\/2021","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-04-07
)
)