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 |
|---|
| 2011/07/26 |
SUPPL-80（补充） |
Approval |
Labeling |
|
|
|
| 2010/12/06 |
SUPPL-79（补充） |
Approval |
Labeling |
|
|
|
| 2008/11/25 |
SUPPL-78（补充） |
Approval |
Labeling |
|
|
|
| 2002/12/16 |
SUPPL-73（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/09/26 |
SUPPL-72（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/04/19 |
SUPPL-71（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/01/10 |
SUPPL-69（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/11/28 |
SUPPL-70（补充） |
Approval |
Labeling |
|
|
|
| 2001/08/22 |
SUPPL-67（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/05/09 |
SUPPL-68（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/06/15 |
SUPPL-65（补充） |
Approval |
Labeling |
|
|
|
| 1999/06/15 |
SUPPL-64（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/06/15 |
SUPPL-63（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/05/05 |
SUPPL-62（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/01/27 |
SUPPL-59（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/21 |
SUPPL-61（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/21 |
SUPPL-60（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/21 |
SUPPL-58（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/08/11 |
SUPPL-57（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/08/11 |
SUPPL-56（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/11/02 |
SUPPL-55（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/01/24 |
SUPPL-54（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/08/13 |
SUPPL-53（补充） |
Approval |
Labeling |
|
|
|
| 1992/03/27 |
SUPPL-51（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/03/27 |
SUPPL-50（补充） |
Approval |
Labeling |
|
|
|
| 1992/03/27 |
SUPPL-49（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/02/03 |
SUPPL-52（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/09/15 |
SUPPL-48（补充） |
Approval |
Labeling |
|
|
|
| 1988/11/02 |
SUPPL-47（补充） |
Approval |
Labeling |
|
|
|
| 1988/10/28 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/10/28 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/01/21 |
SUPPL-42（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/01/21 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/01/21 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/01/21 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/01/20 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/03/03 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/01/16 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/01/16 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/01/16 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/04/09 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/01/07 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/04/30 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/07/29 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/07/29 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/07/29 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/02/28 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/12/15 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/11/08 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/11/08 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/11/08 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/06/03 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/06/03 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1981/11/20 |
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:TRIFLUOPERAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:EQ 2MG BASE 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 |
|---|
| 085786 |
001 |
ANDA |
TRIFLUOPERAZINE HYDROCHLORIDE |
TRIFLUOPERAZINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 040209 |
002 |
ANDA |
TRIFLUOPERAZINE HYDROCHLORIDE |
TRIFLUOPERAZINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
1997/07/07
|
MYLAN |