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-77(补充) |
Approval |
Labeling |
|
|
|
2010/12/06 |
SUPPL-76(补充) |
Approval |
Labeling |
|
|
|
2008/11/25 |
SUPPL-75(补充) |
Approval |
Labeling |
|
|
|
2002/12/16 |
SUPPL-71(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/12/11 |
SUPPL-70(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/04/19 |
SUPPL-69(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2002/01/10 |
SUPPL-67(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/11/28 |
SUPPL-68(补充) |
Approval |
Labeling |
|
|
|
2001/08/22 |
SUPPL-65(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
2001/05/09 |
SUPPL-66(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/06/15 |
SUPPL-64(补充) |
Approval |
Labeling |
|
|
|
1999/06/15 |
SUPPL-63(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/06/15 |
SUPPL-62(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1999/05/05 |
SUPPL-61(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1998/01/27 |
SUPPL-58(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/10/21 |
SUPPL-60(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/10/21 |
SUPPL-59(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/10/21 |
SUPPL-57(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/08/11 |
SUPPL-56(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1997/08/11 |
SUPPL-55(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1995/11/02 |
SUPPL-54(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1994/01/24 |
SUPPL-53(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/08/13 |
SUPPL-52(补充) |
Approval |
Labeling |
|
|
|
1992/03/27 |
SUPPL-49(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/03/27 |
SUPPL-48(补充) |
Approval |
Labeling |
|
|
|
1992/03/27 |
SUPPL-47(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1992/02/03 |
SUPPL-51(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1989/09/15 |
SUPPL-45(补充) |
Approval |
Labeling |
|
|
|
1988/11/02 |
SUPPL-44(补充) |
Approval |
Labeling |
|
|
|
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) |
|
|
|
1988/01/21 |
SUPPL-38(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1987/01/20 |
SUPPL-34(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) |
|
|
|
1986/01/16 |
SUPPL-29(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) |
|
|
|
1983/08/01 |
SUPPL-16(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/01 |
SUPPL-14(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/08/01 |
SUPPL-13(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1983/02/28 |
SUPPL-6(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/12/15 |
SUPPL-1(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/12/09 |
SUPPL-12(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/12/09 |
SUPPL-11(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/12/09 |
SUPPL-10(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/04 |
SUPPL-7(补充) |
Approval |
Manufacturing (CMC) |
|
|
|
1982/06/04 |
SUPPL-3(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 5MG 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 |
085789 |
001 |
ANDA |
TRIFLUOPERAZINE HYDROCHLORIDE |
TRIFLUOPERAZINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
040209 |
003 |
ANDA |
TRIFLUOPERAZINE HYDROCHLORIDE |
TRIFLUOPERAZINE HYDROCHLORIDE |
TABLET;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
1997/07/07
|
MYLAN |