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 |
|---|
| 1974/07/09 |
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-122（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2017/02/23 |
SUPPL-119（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/08/29 |
SUPPL-118（补充） |
Approval |
Labeling-Container/Carton Labels |
UNKNOWN
|
|
|
| 2011/09/13 |
SUPPL-114（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2010/12/03 |
SUPPL-111（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2009/08/24 |
SUPPL-108（补充） |
Approval |
Labeling |
|
|
|
| 2008/11/19 |
SUPPL-105（补充） |
Approval |
Labeling |
|
|
|
| 2002/11/25 |
SUPPL-90（补充） |
Approval |
Labeling |
|
|
|
| 1999/03/22 |
SUPPL-89（补充） |
Approval |
Labeling |
|
|
|
| 1999/03/22 |
SUPPL-88（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/02/05 |
SUPPL-87（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/09/16 |
SUPPL-86（补充） |
Approval |
Labeling |
|
|
|
| 1991/12/31 |
SUPPL-85（补充） |
Approval |
Labeling |
|
|
|
| 1990/12/18 |
SUPPL-84（补充） |
Approval |
Labeling |
|
|
|
| 1989/04/14 |
SUPPL-83（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/07/05 |
SUPPL-81（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/04/26 |
SUPPL-82（补充） |
Approval |
Labeling |
|
|
|
| 1988/03/08 |
SUPPL-80（补充） |
Approval |
Labeling |
|
|
|
| 1987/12/08 |
SUPPL-79（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/12/08 |
SUPPL-78（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/12/08 |
SUPPL-76（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/12/08 |
SUPPL-75（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/07/10 |
SUPPL-74（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/07/10 |
SUPPL-73（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/03/11 |
SUPPL-68（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/12/20 |
SUPPL-72（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/08/28 |
SUPPL-69（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/06/15 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/04/26 |
SUPPL-62（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:TABLET;ORAL; 规格:25MG; 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 |
|---|
| 084112 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
UPSHER SMITH LABS |
| 209755 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2018/09/10
|
AMNEAL PHARMS CO |
| 213368 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/01/17
|
ZYDUS LIFESCIENCES |
| 213590 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2020/08/31
|
APPCO |
| 214256 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AB |
2020/10/26
|
SUN PHARM |
| 212996 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/01/22
|
LANNETT CO INC |
| 212144 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/03/23
|
GLENMARK PHARMS LTD |
| 215659 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/10/25
|
TEVA PHARMS |
| 212630 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2021/11/29
|
CHARTWELL RX |
| 214827 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2022/01/27
|
MSN |
| 213327 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2023/07/13
|
LUPIN |
| 217350 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2023/07/18
|
ALEMBIC |
| 216788 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2025/04/25
|
AUROBINDO PHARMA LTD |