药品名称 | HYDERGINE | 申请号 | 009087 | 产品号 | 001 | 活性成分 | ERGOLOID MESYLATES | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;SUBLINGUAL | 规格 | 1MG | 治疗等效代码 | | 参比药物 | 否 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | NOVARTIS PHARMACEUTICALS CORP
| 化学类型 | New molecular entity (NME) | 审评分类 | Standard review drug |
|
|
与本品相关的专利信息(来自橙皮书Orange Book) | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | 无 | 历史专利信息 | 无 |
|
与本品相关的市场独占权保护信息 | 独占权代码 | 失效日期 | 无 | 历史市场独占权保护信息 | 无 |
|
与药品注册相关的信息 | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | 无 |
|
药品注册审批历史信息 | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | 009087 | 047 | AP | 2000/05/10 | Manufacturing Change or Addition | 009087 | 046 | AP | 1999/04/21 | Package Change | 009087 | 045 | AP | 1998/11/12 | Labeling Revision | 009087 | 044 | AP | 1993/09/14 | Package Change | 009087 | 041 | AP | 1993/04/06 | Control Supplement | 009087 | 039 | AP | 1989/11/07 | Package Change | 009087 | 038 | AP | 1987/05/26 | Control Supplement | 009087 | 036 | AP | 1983/10/26 | Labeling Revision | 009087 | 035 | AP | 1983/08/26 | Control Supplement | 009087 | 033 | AP | 1983/02/03 | Labeling Revision | 009087 | 031 | AP | 1983/01/19 | Manufacturing Change or Addition | 009087 | 030 | AP | 1981/08/10 | Manufacturing Change or Addition | 009087 | 029 | AP | 1981/09/02 | Control Supplement | 009087 | 028 | AP | 1981/01/19 | Package Change | 009087 | 027 | AP | 1981/02/24 | Control Supplement | 009087 | 026 | AP | 1979/12/11 | Manufacturing Change or Addition | 009087 | 025 | AP | 1979/06/14 | Package Change | 009087 | 024 | AP | 1981/02/04 | Labeling Revision | 009087 | 022 | AP | 1978/07/13 | Package Change | 009087 | 021 | AP | 1978/10/16 | Manufacturing Change or Addition | 009087 | 020 | AP | 1978/06/27 | Expiration Date Change | 009087 | 019 | AP | 1978/04/14 | Labeling Revision | 009087 | 017 | AP | 1978/03/20 | Package Change | 009087 | 013 | AP | 1976/07/28 | Manufacturing Change or Addition | 009087 | 012 | AP | 1976/06/30 | Package Change | 009087 | 011 | AP | 1976/02/23 | Control Supplement | 009087 | 009 | AP | 1975/11/13 | Control Supplement | 009087 | 008 | AP | 1975/10/06 | Control Supplement | 009087 | 007 | AP | 1975/06/25 | Control Supplement | 009087 | 006 | AP | 1975/06/02 | General Efficacy (MarkIV) | 009087 | 005 | AP | 1974/12/13 | Control Supplement | 009087 | 004 | AP | 1975/04/16 | Other Amendment | 009087 | 002 | AP | 1974/06/25 | Control Supplement | 009087 | 000 | AP | 1953/11/05 | Approval |
|