药品名称 | M.V.I.-12 (WITHOUT VITAMIN K) | 申请号 | 008809 | 产品号 | 006 | 活性成分 | ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML | 治疗等效代码 | | 参比药物 | 是 | 批准日期 | 2004/09/09 | 申请机构 | HOSPIRA INC
| 化学类型 | New combination | 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 | ODE | 2011/09/09 |
|
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 | 008809 | 066 | AP | Letter | 2013/03/28 | 下载 | 008809 | 066 | AP | Label | 2013/04/01 | 下载 | 008809 | 065 | AP | Letter | 2012/06/15 | 下载 | 008809 | 065 | AP | Label | 2012/06/18 | 下载 | 008809 | 054 | AP | Letter | 2004/09/10 | 下载 | 008809 | 054 | AP | Label | 2004/09/10 | 下载 | 008809 | 052 | AP | Letter | 2004/04/29 | 下载 | 008809 | 052 | AP | Label | 2004/05/04 | 下载 | 008809 | 046 | AP | Letter | 2002/06/04 | 下载 |
|
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 | 008809 | 072 | AP | 2015/09/18 | Manufacturing Change or Addition | 008809 | 069 | AP | 2013/03/19 | Manufacturing Change or Addition | 008809 | 067 | AP | 2015/02/03 | Manufacturing Change or Addition | 008809 | 066 | AP | 2013/03/26 | Labeling Revision | 008809 | 065 | AP | 2012/06/14 | Labeling Revision | 008809 | 054 | AP | 2004/09/09 | New or Modified Indication | 008809 | 052 | AP | 2004/04/22 | Formulation Revision | 008809 | 048 | AP | 2002/11/14 | Control Supplement | 008809 | 047 | AP | 2002/06/04 | Control Supplement | 008809 | 046 | AP | 2002/06/04 | Labeling Revision | 008809 | 045 | AP | 2001/04/17 | Manufacturing Change or Addition | 008809 | 044 | AP | 2001/04/17 | Manufacturing Change or Addition | 008809 | 043 | AP | 2001/04/10 | Manufacturing Change or Addition | 008809 | 042 | AP | 1999/08/02 | Control Supplement | 008809 | 041 | AP | 1999/05/25 | Control Supplement | 008809 | 040 | AP | 1998/11/18 | Control Supplement | 008809 | 039 | AP | 1998/05/12 | Package Change | 008809 | 038 | AP | 1997/12/31 | Package Change | 008809 | 037 | AP | 1998/03/30 | Manufacturing Change or Addition | 008809 | 036 | AP | 1997/09/22 | Control Supplement | 008809 | 035 | AP | 1997/02/13 | Control Supplement | 008809 | 033 | AP | 1996/01/19 | Control Supplement | 008809 | 031 | AP | 1995/10/27 | Control Supplement | 008809 | 030 | AP | 1995/05/26 | Control Supplement | 008809 | 029 | AP | 1993/02/24 | Control Supplement | 008809 | 028 | AP | 1993/02/03 | Package Change | 008809 | 027 | AP | 1993/02/02 | Package Change | 008809 | 025 | AP | 1991/04/19 | Labeling Revision | 008809 | 024 | AP | 1990/12/07 | Package Change | 008809 | 023 | AP | 1989/06/22 | Labeling Revision | 008809 | 021 | AP | 1985/08/08 | Labeling Revision | 008809 | 020 | AP | 1985/04/24 | Package Change | 008809 | 019 | AP | 1985/04/25 | Package Change | 008809 | 018 | AP | 1984/09/20 | Labeling Revision | 008809 | 000 | AP | 1953/02/20 | Approval |
|