Application Sponsors
ANDA 214790 | ASCENT PHARMS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | EQ 25MG BASE | 0 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
002 | TABLET;ORAL | EQ 50MG BASE | 0 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
003 | TABLET;ORAL | EQ 100MG BASE | 0 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-05-03 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
ASCENT PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 214790
[companyName] => ASCENT PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-05-03
)
)