اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
AMBIEN CR از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 021774
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMBIEN CR | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
Yes | Yes |
AMBIEN CR | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription |
AB |
Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/02/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021774lbl.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/18/2019 | SUPPL-27 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s046, 021774Orig1s027ltr.pdf |
||
02/06/2019 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019908Orig1s045, 021774Orig1s026ltr.pdf |
||
09/14/2018 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021774s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019908Orig1s042,021774Orig1s023ltr.pdf |
||
03/03/2017 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021774s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019908Orig1s038,021774Orig1s019ltr.pdf |
||
12/02/2016 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021774s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019908Orig1s037,021774Orig1s018ltr.pdf |
||
08/11/2016 | SUPPL-17 | Labeling-Package Insert |
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-16 | Labeling-Package Insert |
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-15 | Labeling-Package Insert |
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 |
||
04/19/2013 | SUPPL-13 | Labeling-Package Insert |
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-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021774s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021774s010ltr.pdf |
||
12/20/2007 | SUPPL-8 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf |
||
12/20/2007 | SUPPL-7 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf |
||
12/20/2007 | SUPPL-5 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf |
||
12/20/2007 | SUPPL-4 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf |
||
12/20/2007 | SUPPL-3 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021774s003,s004,s005,s007,s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021774Orig1s003.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/18/2019 | SUPPL-27 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s027lbl.pdf | |
02/06/2019 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021774s026lbl.pdf | |
09/14/2018 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021774s023lbl.pdf | |
03/03/2017 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021774s019lbl.pdf | |
12/02/2016 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021774s018lbl.pdf | |
08/11/2016 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019908s036,021774s017lbl.pdf | |
10/07/2014 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019908s035,021774s016lbl.pdf | |
04/19/2013 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf | |
04/19/2013 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019908s032s034,021774s013s015lbl.pdf | |
04/14/2010 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021774s010lbl.pdf | |
12/20/2007 | SUPPL-8 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf | |
12/20/2007 | SUPPL-7 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf | |
12/20/2007 | SUPPL-5 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf | |
12/20/2007 | SUPPL-4 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf | |
12/20/2007 | SUPPL-3 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021774s003s004s005s007s008lbl.pdf | |
09/02/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021774lbl.pdf |
AMBIEN CR
TABLET, EXTENDED RELEASE;ORAL; 12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMBIEN CR | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021774 | SANOFI AVENTIS US |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078179 | ACTAVIS ELIZABETH |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090153 | ACTAVIS LABS FL INC |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078148 | ANCHEN PHARMS |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200266 | APOTEX INC |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213592 | BRECKENRIDGE |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078970 | LUPIN LTD |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090107 | SANDOZ |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204170 | SUN PHARM |
TABLET, EXTENDED RELEASE;ORAL; 6.25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMBIEN CR | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021774 | SANOFI AVENTIS US |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078179 | ACTAVIS ELIZABETH |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090153 | ACTAVIS LABS FL INC |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078148 | ANCHEN PHARMS |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200266 | APOTEX INC |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213592 | BRECKENRIDGE |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078970 | LUPIN LTD |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090107 | SANDOZ |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204170 | SUN PHARM |
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