Documents
Application Sponsors
| NDA 021774 | SANOFI AVENTIS US | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | 12.5MG | 1 | AMBIEN CR | ZOLPIDEM TARTRATE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | 6.25MG | 1 | AMBIEN CR | ZOLPIDEM TARTRATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2005-09-02 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2007-12-20 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2007-12-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2007-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2007-12-20 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2007-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2010-04-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 13 | AP | 2013-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2013-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2014-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2016-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2016-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2017-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2022-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2018-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2022-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2019-02-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 27 | AP | 2019-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2022-02-23 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 31 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 21 | Null | 31 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 15 |
| SUPPL | 27 | Null | 15 |
| SUPPL | 28 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21774
[companyName] => SANOFI AVENTIS US
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021774s027lbl.pdf#page=26"]
[products] => [{"drugName":"AMBIEN CR","activeIngredients":"ZOLPIDEM TARTRATE","strength":"12.5MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AMBIEN CR","activeIngredients":"ZOLPIDEM TARTRATE","strength":"6.25MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
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[originalApprovals] => [{"actionDate":"AMBIEN CR","submission":"ZOLPIDEM TARTRATE","actionType":"12.5MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AMBIEN CR","submission":"ZOLPIDEM TARTRATE","actionType":"6.25MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-08-18
)
)