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 |
2021/03/23 |
ORIG-1(原始申请) |
Approval |
|
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:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 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 |
083386 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
UPSHER SMITH LABS |
209755 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2018/09/10
|
AMNEAL PHARMS CO |
213368 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/01/17
|
ZYDUS |
213590 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/08/31
|
APPCO |
214256 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2020/10/26
|
SUN PHARM |
212996 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/01/22
|
LANNETT CO INC |
212144 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/03/23
|
GLENMARK PHARMS LTD |
215659 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/10/25
|
TEVA PHARMS |
212630 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2021/11/29
|
ZAMEER PHARMS |
213327 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2023/07/13
|
LUPIN |
217350 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2023/07/18
|
ALEMBIC |
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 |
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 |
Prescription |
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
|
ZAMEER PHARMS |
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 |
活性成分:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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 |
084113 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
UPSHER SMITH LABS |
209755 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2018/09/10
|
AMNEAL PHARMS CO |
213368 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/01/17
|
ZYDUS |
213590 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/08/31
|
APPCO |
214256 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/10/26
|
SUN PHARM |
212996 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/01/22
|
LANNETT CO INC |
212144 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/03/23
|
GLENMARK PHARMS LTD |
215659 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/10/25
|
TEVA PHARMS |
212630 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2021/11/29
|
ZAMEER PHARMS |
214827 |
002 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2022/01/27
|
MSN |
213327 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/07/13
|
LUPIN |
217350 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2023/07/18
|
ALEMBIC |
活性成分:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 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 |
084114 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
UPSHER SMITH LABS |
209755 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2018/09/10
|
AMNEAL PHARMS CO |
213368 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/01/17
|
ZYDUS |
213590 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/08/31
|
APPCO |
214256 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/10/26
|
SUN PHARM |
212996 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/01/22
|
LANNETT CO INC |
212144 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/03/23
|
GLENMARK PHARMS LTD |
215659 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/10/25
|
TEVA PHARMS |
212630 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2021/11/29
|
ZAMEER PHARMS |
214827 |
003 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2022/01/27
|
MSN |
213327 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/07/13
|
LUPIN |
217350 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2023/07/18
|
ALEMBIC |
活性成分:CHLORPROMAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:200MG 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 |
084115 |
001 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
UPSHER SMITH LABS |
209755 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2018/09/10
|
AMNEAL PHARMS CO |
213368 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/01/17
|
ZYDUS |
213590 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/08/31
|
APPCO |
214256 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2020/10/26
|
SUN PHARM |
212996 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/01/22
|
LANNETT CO INC |
212144 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/03/23
|
GLENMARK PHARMS LTD |
215659 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/10/25
|
TEVA PHARMS |
212630 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2021/11/29
|
ZAMEER PHARMS |
214827 |
004 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2022/01/27
|
MSN |
213327 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/07/13
|
LUPIN |
217350 |
005 |
ANDA |
CHLORPROMAZINE HYDROCHLORIDE |
CHLORPROMAZINE HYDROCHLORIDE |
TABLET;ORAL |
200MG |
Prescription |
No |
No |
AB |
2023/07/18
|
ALEMBIC |