Application Sponsors
ANDA 209293 | SCIECURE PHARMA INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 12.5MG BASE | 0 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE |
002 | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG BASE | 0 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE |
003 | TABLET, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | 0 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-06-12 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
SCIECURE PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209293
[companyName] => SCIECURE PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 12.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PAROXETINE HYDROCHLORIDE","activeIngredients":"PAROXETINE HYDROCHLORIDE","strength":"EQ 37.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-06-12
)
)