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 |