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 |
|---|
| 2013/04/11 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2006/04/06 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 2006/04/06 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2005/08/19 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1998/12/01 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/05/23 |
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 |
| 218936 |
003 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2024/09/12
|
GRAVITI PHARMS |
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 |
| 218936 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
TABLET;ORAL |
5MG |
Prescription |
No |
No |
AB |
2024/09/12
|
GRAVITI PHARMS |