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 |
|---|
| 2023/06/30 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/06/11 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/06/11 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/11/23 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
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:TEMAZEPAM 剂型/给药途径:CAPSULE;ORAL 规格:7.5MG 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 |
|---|
| 018163 |
003 |
NDA |
RESTORIL |
TEMAZEPAM |
CAPSULE;ORAL |
7.5MG |
Prescription |
Yes |
No |
AB |
1991/10/25
|
SPECGX LLC |
| 078581 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2009/09/08
|
SUN PHARM INDUSTRIES |
| 071457 |
002 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2012/06/22
|
NOVEL LABS INC |
| 201781 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2015/06/04
|
PRINSTON INC |
| 203482 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
7.5MG |
Discontinued |
No |
No |
AB |
2016/05/23
|
AMNEAL PHARMS |
| 211542 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2018/11/23
|
ALEMBIC |
| 217875 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2023/08/24
|
ALKEM LABS LTD |
活性成分:TEMAZEPAM 剂型/给药途径:CAPSULE;ORAL 规格:15MG 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 |
|---|
| 018163 |
001 |
NDA |
RESTORIL |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
SPECGX LLC |
| 071456 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AB |
1987/04/21
|
NOVEL LABS INC |
| 071620 |
002 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AB |
1987/08/07
|
ACTAVIS ELIZABETH |
| 071427 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AB |
1988/01/12
|
CHARTWELL RX |
| 201781 |
002 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2015/06/04
|
PRINSTON INC |
| 203482 |
002 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Discontinued |
No |
No |
AB |
2016/05/23
|
AMNEAL PHARMS |
| 211542 |
002 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2018/11/23
|
ALEMBIC |
| 217875 |
002 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2023/08/24
|
ALKEM LABS LTD |
活性成分:TEMAZEPAM 剂型/给药途径:CAPSULE;ORAL 规格:22.5MG 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 |
|---|
| 018163 |
004 |
NDA |
RESTORIL |
TEMAZEPAM |
CAPSULE;ORAL |
22.5MG |
Prescription |
Yes |
No |
AB |
2004/11/02
|
SPECGX LLC |
| 071175 |
002 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
22.5MG |
Discontinued |
No |
No |
AB |
2009/09/14
|
SUN PHARM INDUSTRIES |
| 071457 |
003 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
22.5MG |
Prescription |
No |
No |
AB |
2012/06/22
|
NOVEL LABS INC |
| 201781 |
003 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
22.5MG |
Prescription |
No |
No |
AB |
2015/06/04
|
PRINSTON INC |
| 203482 |
003 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
22.5MG |
Discontinued |
No |
No |
AB |
2016/05/23
|
AMNEAL PHARMS |
| 211542 |
003 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
22.5MG |
Prescription |
No |
No |
AB |
2018/11/23
|
ALEMBIC |
| 217875 |
003 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
22.5MG |
Prescription |
No |
No |
AB |
2023/08/24
|
ALKEM LABS LTD |
活性成分:TEMAZEPAM 剂型/给药途径:CAPSULE;ORAL 规格:30MG 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 |
|---|
| 018163 |
002 |
NDA |
RESTORIL |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
SPECGX LLC |
| 071457 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
1987/04/21
|
NOVEL LABS INC |
| 071620 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
1987/08/07
|
ACTAVIS ELIZABETH |
| 071428 |
001 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
1988/01/12
|
CHARTWELL RX |
| 201781 |
004 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2015/06/04
|
PRINSTON INC |
| 203482 |
004 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Discontinued |
No |
No |
AB |
2016/05/23
|
AMNEAL PHARMS |
| 211542 |
004 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2018/11/23
|
ALEMBIC |
| 217875 |
004 |
ANDA |
TEMAZEPAM |
TEMAZEPAM |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2023/08/24
|
ALKEM LABS LTD |