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 |
|---|
| 1974/02/13 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2020/02/05 |
SUPPL-167（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2017/02/23 |
SUPPL-166（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2015/11/03 |
SUPPL-165（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 1999/02/19 |
SUPPL-163（补充） |
Approval |
Manufacturing (CMC)-Microbiology-Processing |
|
|
|
| 1999/02/02 |
SUPPL-162（补充） |
Approval |
Manufacturing (CMC)-Microbiology-Processing |
|
|
|
| 1998/03/27 |
SUPPL-160（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/12/04 |
SUPPL-161（补充） |
Approval |
Manufacturing (CMC)-Microbiology-Processing |
|
|
|
| 1995/08/16 |
SUPPL-159（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/05/27 |
SUPPL-157（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/05/11 |
SUPPL-158（补充） |
Approval |
Labeling |
|
|
|
| 1991/07/02 |
SUPPL-152（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/07/02 |
SUPPL-151（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/07/02 |
SUPPL-150（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1991/04/10 |
SUPPL-156（补充） |
Approval |
Labeling |
|
|
|
| 1990/01/11 |
SUPPL-155（补充） |
Approval |
Labeling |
|
|
|
| 1989/10/16 |
SUPPL-153（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/10/16 |
SUPPL-149（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/10/16 |
SUPPL-148（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/04/20 |
SUPPL-138（补充） |
Approval |
Bioequivalence |
|
|
|
| 1989/04/18 |
SUPPL-147（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/04/18 |
SUPPL-146（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/04/18 |
SUPPL-145（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/04/10 |
SUPPL-139（补充） |
Approval |
Bioequivalence |
|
|
|
| 1988/06/30 |
SUPPL-41（补充） |
Approval |
Labeling |
|
|
|
| 1986/06/16 |
SUPPL-137（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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 |
| 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 |