Documents
Application Sponsors
ANDA 077990 | YUNG SHIN PHARM | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | 5MG | 0 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
002 | TABLET;ORAL | 10MG | 0 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
FDA Submissions
| ORIG | 1 | AP | 2007-04-23 | |
LABELING; Labeling | SUPPL | 2 | AP | 2009-10-20 | |
LABELING; Labeling | SUPPL | 3 | AP | 2011-02-04 | |
LABELING; Labeling | SUPPL | 5 | AP | 2014-12-29 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
YUNG SHIN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 77990
[companyName] => YUNG SHIN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)