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 |
|---|
| 2005/08/10 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2023/01/17 |
SUPPL-14（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2022/12/14 |
SUPPL-13（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2021/02/05 |
SUPPL-10（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2021/01/25 |
SUPPL-8（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-7（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2013/01/28 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 2013/01/28 |
SUPPL-3（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert,REMS-Proposal |
|
|
|
| 2010/06/27 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
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, ORALLY DISINTEGRATING;ORAL; 规格:0.125MG; 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 |
|---|
| 077171 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.125MG |
Prescription |
No |
No |
AB |
2005/08/03
|
PH HEALTH |
| 077194 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.125MG |
Prescription |
No |
No |
AB |
2005/08/10
|
BARR |
| 078654 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.125MG |
Discontinued |
No |
No |
AB |
2014/08/27
|
SUN PHARM INDS INC |
| 211033 |
001 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.125MG |
Prescription |
No |
No |
AB |
2019/06/28
|
ALEMBIC |
>>>活性成分:CLONAZEPAM; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;ORAL; 规格:0.25MG; 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 |
|---|
| 077171 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2005/08/03
|
PH HEALTH |
| 077194 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2005/08/10
|
BARR |
| 078654 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.25MG |
Discontinued |
No |
No |
AB |
2014/08/27
|
SUN PHARM INDS INC |
| 211033 |
002 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.25MG |
Prescription |
No |
No |
AB |
2019/06/28
|
ALEMBIC |
>>>活性成分:CLONAZEPAM; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;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 |
|---|
| 077171 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2005/08/03
|
PH HEALTH |
| 077194 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2005/08/10
|
BARR |
| 078654 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Discontinued |
No |
No |
AB |
2014/08/27
|
SUN PHARM INDS INC |
| 211033 |
003 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
0.5MG |
Prescription |
No |
No |
AB |
2019/06/28
|
ALEMBIC |
>>>活性成分:CLONAZEPAM; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;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 |
|---|
| 077171 |
004 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
Yes |
AB |
2005/08/03
|
PH HEALTH |
| 077194 |
004 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
No |
AB |
2005/08/10
|
BARR |
| 078654 |
004 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Discontinued |
No |
No |
AB |
2014/08/27
|
SUN PHARM INDS INC |
| 211033 |
004 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
1MG |
Prescription |
No |
No |
AB |
2019/06/28
|
ALEMBIC |
>>>活性成分:CLONAZEPAM; 剂型/给药途径:TABLET, ORALLY DISINTEGRATING;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 |
|---|
| 077171 |
005 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2005/08/03
|
PH HEALTH |
| 077194 |
005 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2005/08/10
|
BARR |
| 078654 |
005 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Discontinued |
No |
No |
AB |
2014/08/27
|
SUN PHARM INDS INC |
| 211033 |
005 |
ANDA |
CLONAZEPAM |
CLONAZEPAM |
TABLET, ORALLY DISINTEGRATING;ORAL |
2MG |
Prescription |
No |
No |
AB |
2019/06/28
|
ALEMBIC |