Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019908
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMBIEN | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AMBIEN | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/16/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S000_AmbienTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/23/2022 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019908Orig1s040, s044, s047; 021774Orig1s021, s025, s028ltr.pdf | |
| 08/18/2019 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s046, 021774Orig1s027ltr.pdf | |
| 02/06/2019 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s045, 021774Orig1s026ltr.pdf | |
| 02/23/2022 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019908Orig1s040, s044, s047; 021774Orig1s021, s025, s028ltr.pdf | |
| 09/14/2018 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019908s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019908Orig1s042,021774Orig1s023ltr.pdf | |
| 02/23/2022 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019908Orig1s040, s044, s047; 021774Orig1s021, s025, s028ltr.pdf | |
| 03/03/2017 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019908s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019908Orig1s038,021774Orig1s019ltr.pdf | |
| 12/02/2016 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019908Orig1s037,021774Orig1s018ltr.pdf | |
| 08/11/2016 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021774Orig1s017,019908Orig1s036ltr.pdf | |
| 10/07/2014 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019908Orig1s035,021774Orig1s016ltr.pdf | |
| 04/19/2013 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf | |
| 06/05/2013 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019908Orig1s032,s034,021774Orig1s013,s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019908Orig1s032,s034,021774Orig1s013,s015review.pdf | |
| 04/14/2010 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019908s029ltr.pdf | |
| 05/07/2008 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019908s024, s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019908Orig1s027.pdf | |
| 10/04/2007 | SUPPL-25 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019908Orig1s025.pdf |
| 10/04/2007 | SUPPL-24 |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf | |
| 03/28/2007 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s022ltr.pdf | |
| 10/04/2007 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019908s020s024s025ltr.pdf |
| 09/25/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/2002 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/2002 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/15/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/04/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/14/1995 | SUPPL-2 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019908_S002_AMBIEN_AP.pdf |
| 07/14/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/23/2022 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf | |
| 02/23/2022 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf | |
| 02/23/2022 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019908s40s044s047lbl.pdf | |
| 08/18/2019 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s046lbl.pdf | |
| 02/06/2019 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s045lbl.pdf | |
| 09/14/2018 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019908s042lbl.pdf | |
| 03/03/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019908s038lbl.pdf | |
| 12/02/2016 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s037lbl.pdf | |
| 08/11/2016 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf | |
| 10/07/2014 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf | |
| 04/19/2013 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf | |
| 04/19/2013 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf | |
| 04/14/2010 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019908s029lbl.pdf | |
| 05/07/2008 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019908s027lbl.pdf | |
| 03/28/2007 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019908s022lbl.pdf |
AMBIEN
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMBIEN | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 019908 | SANOFI AVENTIS US |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077214 | ACME LABS |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077884 | APOTEX INC |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 078413 | AUROBINDO PHARMA |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077388 | CHARTWELL MOLECULAR |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077322 | SANDOZ |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 076410 | TEVA |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Prescription | No | AB | 077903 | TORRENT PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMBIEN | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 019908 | SANOFI AVENTIS US |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 077214 | ACME LABS |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 077884 | APOTEX INC |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 078413 | AUROBINDO PHARMA |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 077388 | CHARTWELL MOLECULAR |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 077322 | SANDOZ |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 076410 | TEVA |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET;ORAL | Prescription | No | AB | 077903 | TORRENT PHARMS |