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 |
|---|
| 2024/07/22 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>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 |
|---|
| 无 |
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:CAPSULE, EXTENDED RELEASE;ORAL; 规格:15MG; 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 |
|---|
| 021777 |
001 |
NDA |
AMRIX |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
Yes |
No |
AB |
2007/02/01
|
TEVA PHARMS INTL |
| 091281 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2013/01/31
|
TWI PHARMS INC |
| 206703 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Discontinued |
No |
No |
AB |
2018/07/24
|
APOTEX |
| 207314 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2024/07/22
|
MACLEODS PHARMS LTD |
| 214732 |
001 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
15MG |
Prescription |
No |
No |
AB |
2024/08/27
|
NOVAST LABS |
>>>活性成分:CYCLOBENZAPRINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE, EXTENDED RELEASE;ORAL; 规格:30MG; 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 |
|---|
| 021777 |
002 |
NDA |
AMRIX |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
Yes |
Yes |
AB |
2007/02/01
|
TEVA PHARMS INTL |
| 091281 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2013/01/31
|
TWI PHARMS INC |
| 206703 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
Discontinued |
No |
No |
AB |
2018/07/24
|
APOTEX |
| 207314 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2024/07/22
|
MACLEODS PHARMS LTD |
| 214732 |
002 |
ANDA |
CYCLOBENZAPRINE HYDROCHLORIDE |
CYCLOBENZAPRINE HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
30MG |
Prescription |
No |
No |
AB |
2024/08/27
|
NOVAST LABS |