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 |
2015/06/19 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2013/04/11 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2008/04/18 |
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:CYCLOBENZAPRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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 |
071611 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1989/05/03
|
ACTAVIS LABS FL INC |
073541 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1995/05/23
|
ANDA REPOSITORY |
077209 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2005/10/04
|
OXFORD PHARMS |
077563 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2006/04/19
|
JUBILANT CADISTA |
077797 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2007/02/28
|
PRINSTON INC |
078218 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/04/18
|
CHARTWELL RX |
078722 |
003 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/05/12
|
SUN PHARM INDS LTD |
078643 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/09/26
|
AUROBINDO PHARMA |
090478 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2010/07/23
|
INVAGEN PHARMS |
078048 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2011/02/28
|
KVK TECH |
208170 |
003 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
Yes |
AB |
2017/05/31
|
RUBICON |
213324 |
003 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/07/05
|
UNICHEM |
活性成分:CYCLOBENZAPRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格: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 |
077209 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2006/02/03
|
OXFORD PHARMS |
071611 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2006/02/03
|
ACTAVIS LABS FL INC |
073541 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2006/04/06
|
ANDA REPOSITORY |
077563 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2006/04/19
|
JUBILANT CADISTA |
077797 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2007/02/28
|
PRINSTON INC |
078722 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/05/12
|
SUN PHARM INDS LTD |
078643 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2008/09/26
|
AUROBINDO PHARMA |
090478 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2010/07/23
|
INVAGEN PHARMS |
078048 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2011/02/28
|
KVK TECH |
078218 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2015/06/19
|
CHARTWELL RX |
208170 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2017/05/31
|
RUBICON |
213324 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2020/07/06
|
UNICHEM |
活性成分:CYCLOBENZAPRINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:7.5MG 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 |
071611 |
003 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2006/02/03
|
ACTAVIS LABS FL INC |
078722 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2008/05/12
|
SUN PHARM INDS LTD |
208170 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2017/05/31
|
RUBICON |
077563 |
003 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2017/08/25
|
JUBILANT CADISTA |
213324 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2020/07/06
|
UNICHEM |
078218 |
003 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
7.5MG |
Prescription |
No |
No |
AB |
2020/11/03
|
CHARTWELL RX |