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 |
2021/11/10 |
SUPPL-14(补充) |
Approval |
REMS |
|
|
|
2021/07/29 |
SUPPL-13(补充) |
Approval |
REMS |
|
|
|
2021/02/18 |
SUPPL-10(补充) |
Approval |
REMS |
|
|
|
2019/01/16 |
SUPPL-6(补充) |
Approval |
REMS |
|
|
|
2017/05/10 |
SUPPL-5(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/10 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/10 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/10 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/09/17 |
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:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格: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 |
019758 |
001 |
NDA |
CLOZARIL |
CLOZAPINE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
No |
AB |
1989/09/26
|
HERITAGE LIFE |
074949 |
001 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1997/11/26
|
IVAX SUB TEVA PHARMS |
075417 |
001 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1999/05/27
|
MYLAN |
075713 |
001 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2002/11/15
|
SUN PHARM INDS INC |
203807 |
001 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2015/09/17
|
DR REDDYS LABS SA |
202873 |
001 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2015/11/25
|
ACCORD HLTHCARE |
206433 |
001 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2016/11/29
|
AUROBINDO PHARMA |
活性成分:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格:100MG 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 |
019758 |
002 |
NDA |
CLOZARIL |
CLOZAPINE |
TABLET;ORAL |
100MG |
Prescription |
Yes |
Yes |
AB |
1989/09/26
|
HERITAGE LIFE |
074949 |
002 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1997/11/26
|
IVAX SUB TEVA PHARMS |
075417 |
002 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1999/05/27
|
MYLAN |
075713 |
002 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2002/11/15
|
SUN PHARM INDS INC |
076809 |
002 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2005/12/16
|
IVAX SUB TEVA PHARMS |
203807 |
002 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
100MG |
Discontinued |
No |
No |
AB |
2015/09/17
|
DR REDDYS LABS SA |
202873 |
002 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2015/11/25
|
ACCORD HLTHCARE |
206433 |
003 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2016/11/29
|
AUROBINDO PHARMA |
活性成分:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格:50MG 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 |
074949 |
004 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2005/04/25
|
IVAX SUB TEVA PHARMS |
075713 |
003 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2005/08/19
|
SUN PHARM INDS INC |
076809 |
003 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2005/12/16
|
IVAX SUB TEVA PHARMS |
075417 |
004 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2010/04/15
|
MYLAN |
206433 |
002 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2016/11/29
|
AUROBINDO PHARMA |
203807 |
003 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2017/08/22
|
DR REDDYS LABS SA |
019758 |
003 |
NDA |
CLOZARIL |
CLOZAPINE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
No |
AB |
2019/05/20
|
HERITAGE LIFE |
活性成分:CLOZAPINE 剂型/给药途径:TABLET;ORAL 规格:200MG 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 |
076809 |
001 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2005/12/16
|
IVAX SUB TEVA PHARMS |
075417 |
005 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2010/04/15
|
MYLAN |
206433 |
004 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2016/11/29
|
AUROBINDO PHARMA |
203807 |
004 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
200MG |
Discontinued |
No |
No |
AB |
2017/08/22
|
DR REDDYS LABS SA |
075713 |
004 |
ANDA |
CLOZAPINE |
CLOZAPINE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2017/11/07
|
SUN PHARM INDS INC |
019758 |
004 |
NDA |
CLOZARIL |
CLOZAPINE |
TABLET;ORAL |
200MG |
Prescription |
Yes |
No |
AB |
2019/05/20
|
HERITAGE LIFE |