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 |
|---|
| 2020/02/05 |
SUPPL-47（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/02/04 |
SUPPL-46（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/12/03 |
SUPPL-43（补充） |
Approval |
Labeling |
|
|
|
| 2009/06/29 |
SUPPL-42（补充） |
Approval |
Labeling |
|
|
|
| 2008/11/25 |
SUPPL-41（补充） |
Approval |
Labeling |
|
|
|
| 2002/11/25 |
SUPPL-35（补充） |
Approval |
Labeling |
|
|
|
| 2000/09/18 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/10/06 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/10/06 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/09/07 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/09/07 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/04/14 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1998/03/19 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/12/09 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/02/27 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/01/28 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 1989/11/08 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 1989/02/15 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/02/15 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1974/07/25 |
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:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:25MG/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 |
|---|
| 080365 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
Approved Prior to Jan 1, 1982
|
DR REDDYS |
| 083329 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HIKMA |
| 211816 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2020/07/07
|
EUGIA PHARMA |
| 217275 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2024/03/13
|
ZYDUS PHARMS |
| 218229 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2024/09/24
|
DEVA HLDING |
| 216911 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2024/10/04
|
GLAND PHARMA LTD |
| 218272 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2024/11/18
|
ASPIRO |
| 216724 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
25MG/ML |
Prescription |
No |
No |
AP |
2024/12/10
|
THINQ PHARM-CRO PVT |