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-122(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/02/23 |
SUPPL-119(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2016/08/29 |
SUPPL-118(补充) |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
2011/09/13 |
SUPPL-114(补充) |
Approval |
Labeling |
|
|
|
2010/12/03 |
SUPPL-111(补充) |
Approval |
Labeling |
|
|
|
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 |
|
|
|
1990/11/29 |
SUPPL-84(补充) |
Approval |
Labeling |
|
|
|
1989/02/14 |
SUPPL-83(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/07/08 |
SUPPL-81(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/04/26 |
SUPPL-82(补充) |
Approval |
Labeling |
|
|
|
1988/04/14 |
SUPPL-79(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1988/03/08 |
SUPPL-80(补充) |
Approval |
Labeling |
|
|
|
1987/12/07 |
SUPPL-76(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/12/07 |
SUPPL-75(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/03/12 |
SUPPL-74(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/07/10 |
SUPPL-73(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/07/10 |
SUPPL-72(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1986/03/11 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1985/02/01 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1984/04/10 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/04/26 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1974/07/09 |
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: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 |