批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
| 提交状态日期 | 提交号 | 审批结论 | 申请内容分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2022/09/02 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2019/11/29 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/11/29 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/11/05 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/03/19 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/09/11 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
活性成分:ZOLPIDEM TARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:6.25MG 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021774 |
002 |
NDA |
AMBIEN CR |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
6.25MG |
Prescription |
Yes |
No |
AB |
2005/09/02
|
SANOFI AVENTIS US |
| 078148 |
002 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
6.25MG |
Discontinued |
No |
No |
AB |
2011/04/14
|
ENDO OPERATIONS |
| 090107 |
001 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
6.25MG |
Prescription |
No |
No |
AB |
2011/07/01
|
SANDOZ |
| 200266 |
001 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
6.25MG |
Prescription |
No |
No |
AB |
2013/09/10
|
APOTEX |
| 078970 |
001 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
6.25MG |
Prescription |
No |
No |
AB |
2013/09/11
|
LUPIN LTD |
| 204170 |
001 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
6.25MG |
Prescription |
No |
No |
AB |
2017/01/24
|
SUN PHARM |
| 213592 |
001 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
6.25MG |
Discontinued |
No |
No |
AB |
2020/06/04
|
BRECKENRIDGE |
活性成分:ZOLPIDEM TARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:12.5MG 治疗等效代码:AB
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021774 |
001 |
NDA |
AMBIEN CR |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG |
Prescription |
Yes |
Yes |
AB |
2005/09/02
|
SANOFI AVENTIS US |
| 078148 |
001 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG |
Discontinued |
No |
No |
AB |
2010/12/03
|
ENDO OPERATIONS |
| 090107 |
002 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2011/07/01
|
SANDOZ |
| 200266 |
002 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2013/09/10
|
APOTEX |
| 078970 |
002 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2013/09/11
|
LUPIN LTD |
| 204170 |
002 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG |
Prescription |
No |
No |
AB |
2017/01/24
|
SUN PHARM |
| 213592 |
002 |
ANDA |
ZOLPIDEM TARTRATE |
ZOLPIDEM TARTRATE |
TABLET, EXTENDED RELEASE;ORAL |
12.5MG |
Discontinued |
No |
No |
AB |
2020/06/04
|
BRECKENRIDGE |