Documents
Application Sponsors
| NDA 019908 | SANOFI AVENTIS US | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 5MG | 1 | AMBIEN | ZOLPIDEM TARTRATE |
| 002 | TABLET;ORAL | 10MG | 1 | AMBIEN | ZOLPIDEM TARTRATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1992-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 1995-07-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-01-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-10-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-04-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1999-12-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2001-04-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2001-05-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-11-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2002-01-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2002-05-21 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-09-25 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2007-10-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2007-03-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 24 | AP | 2007-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2007-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2008-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2010-04-14 | UNKNOWN |
| LABELING; Labeling | SUPPL | 32 | AP | 2013-04-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2013-06-05 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2013-04-19 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 35 | AP | 2014-10-07 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2016-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2016-12-02 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2017-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2022-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2018-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2022-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2019-02-06 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 46 | AP | 2019-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 47 | AP | 2022-02-23 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 8 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 7 |
| SUPPL | 37 | Null | 7 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 42 | Null | 6 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 47 | Null | 6 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 19908
[companyName] => SANOFI AVENTIS US
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/019908s046lbl.pdf#page=23"]
[products] => [{"drugName":"AMBIEN","activeIngredients":"ZOLPIDEM TARTRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AMBIEN","activeIngredients":"ZOLPIDEM TARTRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/18\/2019","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019908s046lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019908s045lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019908s042lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019908s038lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2016","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019908s037lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2016","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019908s036,021774s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2014","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019908s035,021774s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019908s032s034,021774s013s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019908s032s034,021774s013s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2010","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019908s029lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2008","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019908s027lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2007","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019908s022lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AMBIEN","submission":"ZOLPIDEM TARTRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AMBIEN","submission":"ZOLPIDEM TARTRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-08-18
)
)