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 |
|---|
| 2023/07/21 |
SUPPL-53（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/07/11 |
SUPPL-51（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/12/10 |
SUPPL-50（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/01/16 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 2005/06/15 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 2001/11/02 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/06/12 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/01/21 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/07/16 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/01/18 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/03/31 |
SUPPL-12（补充） |
Approval |
Labeling |
|
|
|
| 1991/06/18 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/12/27 |
SUPPL-11（补充） |
Approval |
Bioequivalence |
|
|
|
| 1989/04/12 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/03/10 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/03/10 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/03/10 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/10/14 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1988/08/17 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/08/12 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/06/14 |
SUPPL-3（补充） |
Approval |
Labeling |
|
|
|
| 1987/04/21 |
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: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 |
| 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
|
AUROLIFE PHARMA LLC |
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 |
| 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
|
AUROLIFE PHARMA LLC |
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 |
| 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
|
AUROLIFE PHARMA LLC |