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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2025/07/24 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 无 |
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:LORAZEPAM; 剂型/给药途径:TABLET;ORAL; 规格:0.5MG; 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 |
|---|
| 071403 |
001 |
|
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
--
|
|
| 017794 |
001 |
NDA |
ATIVAN |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
BAUSCH |
| 071141 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1987/04/21
|
SANDOZ |
| 072926 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1991/10/31
|
WATSON LABS |
| 076045 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2001/08/29
|
SUN PHARM INDS LTD |
| 077754 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2006/05/10
|
OXFORD PHARMS |
| 077396 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2006/12/13
|
ANI PHARMS |
| 078203 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2007/07/30
|
LEADING |
| 078826 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Discontinued |
No |
No |
AB |
2010/06/23
|
AMNEAL PHARMS |
| 203572 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2017/12/22
|
AUROBINDO PHARMA |
| 218597 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2025/07/24
|
GRAVITI PHARMS |
>>>活性成分:LORAZEPAM; 剂型/给药途径:TABLET;ORAL; 规格:1MG; 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 |
|---|
| 071404 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
--
|
SANDOZ |
| 017794 |
002 |
NDA |
ATIVAN |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
BAUSCH |
| 071141 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1987/04/21
|
SANDOZ |
| 072927 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1991/10/31
|
WATSON LABS |
| 076045 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2001/08/29
|
SUN PHARM INDS LTD |
| 077754 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2006/05/10
|
OXFORD PHARMS |
| 077396 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2006/12/13
|
ANI PHARMS |
| 078203 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2007/07/30
|
LEADING |
| 078826 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Discontinued |
No |
No |
AB |
2010/06/23
|
AMNEAL PHARMS |
| 203572 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2017/12/22
|
AUROBINDO PHARMA |
| 218597 |
002 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2025/07/24
|
GRAVITI PHARMS |
>>>活性成分:LORAZEPAM; 剂型/给药途径:TABLET;ORAL; 规格:2MG; 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 |
|---|
| 017794 |
003 |
NDA |
ATIVAN |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
BAUSCH |
| 071141 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1987/04/21
|
SANDOZ |
| 072928 |
001 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1991/10/31
|
WATSON LABS |
| 076045 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2001/08/29
|
SUN PHARM INDS LTD |
| 077754 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2006/05/10
|
OXFORD PHARMS |
| 077396 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2006/12/13
|
ANI PHARMS |
| 078203 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2007/07/30
|
LEADING |
| 078826 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Discontinued |
No |
No |
AB |
2010/06/23
|
AMNEAL PHARMS |
| 203572 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2017/12/22
|
AUROBINDO PHARMA |
| 218597 |
003 |
ANDA |
LORAZEPAM |
LORAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2025/07/24
|
GRAVITI PHARMS |