Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 12.5MG | 0 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 6.25MG | 0 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE |
FDA Submissions
| ORIG | 1 | AP | 2010-12-03 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2014-04-01 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2015-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2019-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-11-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2019-11-19 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 15 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
ANCHEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 78148
[companyName] => ANCHEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"12.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"6.25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"12.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"6.25MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)