药品注册申请号:016774
申请类型:NDA (新药申请)
申请人:NOVARTIS
申请人全名:NOVARTIS PHARMACEUTICALS CORP
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 SERENTIL MESORIDAZINE BESYLATE TABLET;ORAL EQ 10MG BASE No No None 1970/02/27 Approved Prior to Jan 1, 1982 Discontinued
002 SERENTIL MESORIDAZINE BESYLATE TABLET;ORAL EQ 25MG BASE No No None Approved Prior to Jan 1, 1982 Discontinued
003 SERENTIL MESORIDAZINE BESYLATE TABLET;ORAL EQ 50MG BASE No No None Approved Prior to Jan 1, 1982 Discontinued
004 SERENTIL MESORIDAZINE BESYLATE TABLET;ORAL EQ 100MG BASE No No None Approved Prior to Jan 1, 1982 Discontinued
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
2001/07/06 SUPPL 74 Approval Manufacturing (CMC) STANDARD
2001/03/28 SUPPL 75 Approval Manufacturing (CMC) STANDARD
2001/03/15 SUPPL 73 Approval Labeling STANDARD
2000/09/06 SUPPL 72 Approval Labeling STANDARD
1997/03/14 SUPPL 71 Approval Manufacturing (CMC) STANDARD
1995/11/22 SUPPL 70 Approval Manufacturing (CMC) STANDARD
1995/10/17 SUPPL 69 Approval Manufacturing (CMC) STANDARD
1994/08/01 SUPPL 66 Approval Manufacturing (CMC) STANDARD
1994/07/01 SUPPL 61 Approval Manufacturing (CMC) STANDARD
1990/11/30 SUPPL 62 Approval Manufacturing (CMC) STANDARD
1990/03/14 SUPPL 56 Approval Manufacturing (CMC) STANDARD
1989/11/03 SUPPL 59 Approval Manufacturing (CMC) STANDARD
1989/08/15 SUPPL 58 Approval Manufacturing (CMC) STANDARD
1989/05/10 SUPPL 57 Approval Manufacturing (CMC) STANDARD
1987/08/20 SUPPL 54 Approval Manufacturing (CMC) STANDARD
1987/05/26 SUPPL 53 Approval Manufacturing (CMC) STANDARD
1987/04/23 SUPPL 52 Approval Manufacturing (CMC) STANDARD
1986/10/17 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1986/03/24 SUPPL 50 Approval Manufacturing (CMC) STANDARD
1985/10/23 SUPPL 49 Approval Manufacturing (CMC) STANDARD
1985/05/08 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1984/03/14 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1983/01/19 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1982/11/05 SUPPL 43 Approval Labeling STANDARD
1981/06/22 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1981/03/24 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1980/12/10 SUPPL 38 Approval Labeling STANDARD
1980/03/07 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1980/01/16 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1979/08/30 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1979/04/04 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1978/12/08 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1978/06/12 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1978/01/24 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1977/06/03 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1977/06/03 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1976/09/15 SUPPL 28 Approval Labeling STANDARD
1976/08/03 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1976/07/16 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1976/05/25 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1975/12/02 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1975/07/01 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1975/05/06 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1975/03/31 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1975/01/30 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1974/06/07 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1970/02/27 ORIG 1 Approval Type 1 - New Molecular Entity STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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
本品无治疗等效药品
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