Documents
Application Sponsors
ANDA 076442 | SCIEGEN PHARMS INC | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 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
| ORIG | 1 | AP | 2007-04-30 | |
LABELING; Labeling | SUPPL | 2 | AP | 2009-08-31 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
SCIEGEN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 76442
[companyName] => SCIEGEN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SERTRALINE HYDROCHLORIDE","activeIngredients":"SERTRALINE HYDROCHLORIDE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 50MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SERTRALINE HYDROCHLORIDE","submission":"SERTRALINE HYDROCHLORIDE","actionType":"EQ 100MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)