药品注册申请号:016775
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 INJECTABLE;INJECTION EQ 25MG BASE/ML No No None 1970/02/27 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
2001/03/28 SUPPL 42 Approval Manufacturing (CMC) STANDARD
2001/03/15 SUPPL 41 Approval Labeling STANDARD
2000/09/06 SUPPL 40 Approval Labeling STANDARD
1997/03/14 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1994/08/01 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1989/09/22 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1989/08/15 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1989/05/10 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1988/11/21 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1987/08/20 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1987/05/26 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1987/04/23 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1986/11/24 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1986/06/10 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1984/06/26 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1982/11/16 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1982/11/05 SUPPL 13 Approval Labeling STANDARD
1982/10/18 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1981/06/19 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1980/12/10 SUPPL 9 Approval Labeling STANDARD
1980/01/16 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1979/08/30 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1977/08/19 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1977/08/05 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1975/03/31 SUPPL 4 Approval Labeling STANDARD
1975/03/31 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1970/02/27 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
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
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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