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 |
|---|
| 2013/01/11 |
SUPPL-33（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/08/01 |
SUPPL-32（补充） |
Approval |
Labeling |
UNKNOWN
|
|
|
| 2007/02/02 |
SUPPL-31（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/08/12 |
SUPPL-30（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2000/06/23 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/08/17 |
SUPPL-28（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/09/06 |
SUPPL-27（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1993/01/04 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/12/23 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 1991/03/18 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1990/09/25 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1989/08/04 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1988/02/18 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1987/02/06 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1985/06/12 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1985/05/13 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1984/10/15 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1984/10/15 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1952/08/13 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
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:DICYCLOMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/ML 治疗等效代码:AP
| 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 |
|---|
| 008370 |
001 |
NDA |
BENTYL |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
Yes |
Yes |
AP |
1984/10/15
|
ABBVIE |
| 008370 |
002 |
NDA |
BENTYL PRESERVATIVE FREE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
Yes |
Yes |
AP |
1984/10/15
|
ABBVIE |
| 040465 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2003/06/30
|
HIKMA |
| 208353 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2017/02/17
|
AM REGENT |
| 207084 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Discontinued |
No |
No |
AP |
2018/05/04
|
RENEW PHARMS |
| 210979 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2018/07/02
|
FOSUN PHARMA |
| 207076 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2018/11/02
|
SLATE RUN PHARMA |
| 210257 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2019/01/25
|
FRESENIUS KABI USA |
| 206468 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2019/02/01
|
NEXUS |
| 210788 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Discontinued |
No |
No |
AP |
2019/02/11
|
HIKMA |
活性成分:DICYCLOMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/ML 治疗等效代码:AP
| 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 |
|---|
| 008370 |
001 |
NDA |
BENTYL |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
Yes |
Yes |
AP |
1984/10/15
|
ABBVIE |
| 008370 |
002 |
NDA |
BENTYL PRESERVATIVE FREE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
Yes |
Yes |
AP |
1984/10/15
|
ABBVIE |
| 040465 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE) |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2003/06/30
|
HIKMA |
| 208353 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2017/02/17
|
AM REGENT |
| 207084 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Discontinued |
No |
No |
AP |
2018/05/04
|
RENEW PHARMS |
| 210979 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2018/07/02
|
FOSUN PHARMA |
| 207076 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2018/11/02
|
SLATE RUN PHARMA |
| 210257 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2019/01/25
|
FRESENIUS KABI USA |
| 206468 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Prescription |
No |
No |
AP |
2019/02/01
|
NEXUS |
| 210788 |
001 |
ANDA |
DICYCLOMINE HYDROCHLORIDE |
DICYCLOMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
10MG/ML |
Discontinued |
No |
No |
AP |
2019/02/11
|
HIKMA |
