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 |
|---|
| 2016/07/18 |
SUPPL-41（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/07/19 |
SUPPL-40（补充） |
Approval |
REMS |
|
|
|
| 2011/04/08 |
SUPPL-38（补充） |
Approval |
REMS |
|
|
|
| 2011/04/08 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 2009/10/15 |
SUPPL-33（补充） |
Approval |
Labeling |
|
|
|
| 2009/10/15 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 2009/05/07 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 2001/10/16 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 2000/10/13 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1999/12/02 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/12/02 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/02/12 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/02/12 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/10/08 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/22 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1998/06/22 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/22 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/02/18 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1998/01/28 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/11/25 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/07/16 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/09/10 |
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:CLONAZEPAM 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 |
|---|
| 017533 |
001 |
NDA |
KLONOPIN |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
CHEPLAPHARM |
| 074569 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1996/09/10
|
TEVA |
| 074869 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1996/10/31
|
ACTAVIS ELIZABETH |
| 074979 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1997/08/29
|
SANDOZ |
| 075150 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
1998/10/05
|
AUROBINDO PHARMA USA |
| 075468 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2000/10/06
|
RUBICON |
| 077147 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2005/05/02
|
ACCORD HLTHCARE |
| 077856 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2006/06/28
|
PRINSTON INC |
活性成分:CLONAZEPAM 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 |
|---|
| 017533 |
002 |
NDA |
KLONOPIN |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
CHEPLAPHARM |
| 074569 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1996/09/10
|
TEVA |
| 074869 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1996/10/31
|
ACTAVIS ELIZABETH |
| 074979 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1997/08/29
|
SANDOZ |
| 075150 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
1998/10/05
|
AUROBINDO PHARMA USA |
| 075468 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2000/10/06
|
RUBICON |
| 077147 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2005/05/02
|
ACCORD HLTHCARE |
| 077856 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
1MG |
Prescription |
No |
No |
AB |
2006/06/28
|
PRINSTON INC |
活性成分:CLONAZEPAM 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 |
|---|
| 017533 |
003 |
NDA |
KLONOPIN |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
CHEPLAPHARM |
| 074569 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1996/09/10
|
TEVA |
| 074869 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1996/10/31
|
ACTAVIS ELIZABETH |
| 074979 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1997/08/29
|
SANDOZ |
| 075150 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
1998/10/05
|
AUROBINDO PHARMA USA |
| 075468 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2000/10/06
|
RUBICON |
| 077147 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2005/05/02
|
ACCORD HLTHCARE |
| 077856 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET;ORAL |
2MG |
Prescription |
No |
No |
AB |
2006/06/28
|
PRINSTON INC |