药品注册申请号:085785
申请类型:ANDA (仿制药申请)
申请人:SANDOZ
申请人全名:SANDOZ INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE No No AB 1981/11/20 Approved Prior to Jan 1, 1982 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2011/07/26 SUPPL 75 Approval Labeling
2010/12/06 SUPPL 74 Approval Labeling
2008/11/25 SUPPL 73 Approval Labeling
2002/10/18 SUPPL 68 Approval Manufacturing (CMC)
2002/04/19 SUPPL 67 Approval Manufacturing (CMC)
2001/11/28 SUPPL 66 Approval Labeling
2001/08/22 SUPPL 64 Approval Manufacturing (CMC)
2001/05/09 SUPPL 65 Approval Manufacturing (CMC)
1999/06/15 SUPPL 63 Approval Manufacturing (CMC)
1999/05/05 SUPPL 62 Approval Manufacturing (CMC)
1999/03/26 SUPPL 61 Approval Labeling
1999/03/26 SUPPL 60 Approval Manufacturing (CMC)
1998/02/02 SUPPL 59 Approval Manufacturing (CMC)
1998/02/02 SUPPL 58 Approval Manufacturing (CMC)
1998/02/02 SUPPL 57 Approval Manufacturing (CMC)
1997/08/11 SUPPL 56 Approval Manufacturing (CMC)
1997/08/11 SUPPL 55 Approval Manufacturing (CMC)
1996/01/23 SUPPL 54 Approval Manufacturing (CMC)
1994/01/24 SUPPL 53 Approval Manufacturing (CMC)
1992/08/13 SUPPL 52 Approval Labeling
1992/03/27 SUPPL 49 Approval Manufacturing (CMC)
1992/03/27 SUPPL 48 Approval Labeling
1992/03/27 SUPPL 47 Approval Manufacturing (CMC)
1992/02/03 SUPPL 51 Approval Manufacturing (CMC)
1989/09/15 SUPPL 45 Approval Labeling
1988/11/02 SUPPL 44 Approval Labeling
1988/01/21 SUPPL 41 Approval Manufacturing (CMC)
1988/01/21 SUPPL 40 Approval Manufacturing (CMC)
1988/01/21 SUPPL 39 Approval Manufacturing (CMC)
1988/01/21 SUPPL 38 Approval Manufacturing (CMC)
1987/01/20 SUPPL 34 Approval Manufacturing (CMC)
1986/03/03 SUPPL 33 Approval Manufacturing (CMC)
1986/01/17 SUPPL 31 Approval Manufacturing (CMC)
1986/01/17 SUPPL 30 Approval Manufacturing (CMC)
1986/01/17 SUPPL 29 Approval Manufacturing (CMC)
1985/04/09 SUPPL 25 Approval Manufacturing (CMC)
1985/01/07 SUPPL 24 Approval Manufacturing (CMC)
1984/04/30 SUPPL 23 Approval Manufacturing (CMC)
1983/07/29 SUPPL 16 Approval Manufacturing (CMC)
1983/07/29 SUPPL 14 Approval Manufacturing (CMC)
1983/07/29 SUPPL 13 Approval Manufacturing (CMC)
1983/02/28 SUPPL 5 Approval Manufacturing (CMC)
1982/12/15 SUPPL 1 Approval Manufacturing (CMC)
1982/12/09 SUPPL 12 Approval Manufacturing (CMC)
1982/12/09 SUPPL 11 Approval Manufacturing (CMC)
1982/12/09 SUPPL 10 Approval Manufacturing (CMC)
1982/12/09 SUPPL 2 Approval Manufacturing (CMC)
1982/08/04 SUPPL 7 Approval Manufacturing (CMC)
1982/06/03 SUPPL 8 Approval Manufacturing (CMC)
1982/06/03 SUPPL 6 Approval Manufacturing (CMC)
1981/11/20 ORIG 1 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
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
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 1MG 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RLDRSTE Code产品号批准日期申请人
085785 001 ANDA TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB Approved Prior to Jan 1, 1982 SANDOZ
040209 001 ANDA TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE HYDROCHLORIDE TABLET;ORAL EQ 1MG BASE Prescription No No AB 1997/07/07 MYLAN
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