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MESORIDAZINE BESYLATE TABLET;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1970/02/27 Approved Prior to Jan 1, 1982 Discontinued
002 SERENTIL MESORIDAZINE BESYLATE TABLET;ORAL EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
003 SERENTIL MESORIDAZINE BESYLATE TABLET;ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
004 SERENTIL MESORIDAZINE BESYLATE TABLET;ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1970/02/27 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2001/07/06 SUPPL-74（补充） Approval Manufacturing (CMC) STANDARD
2001/03/28 SUPPL-75（补充） Approval Manufacturing (CMC) STANDARD
2001/03/15 SUPPL-73（补充） Approval Labeling STANDARD
2000/09/06 SUPPL-72（补充） Approval Labeling STANDARD
1997/03/14 SUPPL-71（补充） Approval Manufacturing (CMC)-Control STANDARD
1995/11/22 SUPPL-70（补充） Approval Manufacturing (CMC) STANDARD
1995/10/17 SUPPL-69（补充） Approval Manufacturing (CMC)-Control STANDARD
1994/08/01 SUPPL-66（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1994/07/01 SUPPL-61（补充） Approval Manufacturing (CMC)-Control STANDARD
1990/11/30 SUPPL-62（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1990/03/14 SUPPL-56（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1989/11/03 SUPPL-59（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1989/08/15 SUPPL-58（补充） Approval Manufacturing (CMC) STANDARD
1989/05/10 SUPPL-57（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/08/20 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/05/26 SUPPL-53（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/04/23 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/10/17 SUPPL-45（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/03/24 SUPPL-50（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1985/10/23 SUPPL-49（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1985/05/08 SUPPL-47（补充） Approval Manufacturing (CMC) STANDARD
1984/03/14 SUPPL-46（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1983/01/19 SUPPL-42（补充） Approval Manufacturing (CMC)-Control STANDARD
1982/11/05 SUPPL-43（补充） Approval Labeling STANDARD
1981/06/22 SUPPL-41（补充） Approval Manufacturing (CMC) STANDARD
1981/03/24 SUPPL-39（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1980/12/10 SUPPL-38（补充） Approval Labeling STANDARD
1980/03/07 SUPPL-37（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1980/01/16 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1979/08/30 SUPPL-34（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1979/04/04 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
1978/12/08 SUPPL-32（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1978/06/12 SUPPL-33（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1978/01/24 SUPPL-29（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1977/06/03 SUPPL-31（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/06/03 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/09/15 SUPPL-28（补充） Approval Labeling STANDARD
1976/08/03 SUPPL-26（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1976/07/16 SUPPL-25（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1976/05/25 SUPPL-27（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1975/12/02 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/07/01 SUPPL-23（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/05/06 SUPPL-20（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/03/31 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/01/30 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1974/06/07 SUPPL-18（补充） Approval Manufacturing (CMC)-Control 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
无
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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