药品名称 | MAXITROL | 申请号 | 050065 | 产品号 | 002 | 活性成分 | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 市场状态 | 处方药 | 剂型或给药途径 | OINTMENT;OPHTHALMIC | 规格 | 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | 治疗等效代码 | AT | 参比药物 | 是 | 批准日期 | Approved Prior to Jan 1, 1982 | 申请机构 | ALCON LABORATORIES INC
| 化学类型 | | 审评分类 | |
|
|
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 | 050065 | 044 | AP | Letter | 2004/07/21 | 下载 | 050065 | 044 | AP | Label | 2004/07/21 | 下载 | 050065 | 043 | AP | Letter | 2004/07/21 | 下载 | 050065 | 043 | AP | Label | 2004/07/21 | 下载 | 050065 | 040 | AP | Label | 2003/07/28 | 下载 | 050065 | 040 | AP | Letter | 2003/07/28 | 下载 | 050065 | 039 | AP | Label | 2003/07/28 | 下载 | 050065 | 039 | AP | Letter | 2003/07/28 | 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 | 050065 | 060 | AP | 2015/10/06 | Manufacturing Change or Addition | 050065 | 058 | AP | 2012/12/10 | Manufacturing Change or Addition | 050065 | 057 | AP | 2012/12/18 | Manufacturing Change or Addition | 050065 | 044 | AP | 2004/07/15 | Package Change | 050065 | 043 | AP | 2004/07/15 | Labeling Revision | 050065 | 041 | AP | 2002/12/11 | Control Supplement | 050065 | 040 | AP | 2003/07/23 | Labeling Revision | 050065 | 039 | AP | 2003/07/23 | Manufacturing Change or Addition | 050065 | 038 | AP | 2001/02/09 | Manufacturing Change or Addition | 050065 | 037 | AP | 1999/09/28 | Package Change | 050065 | 036 | AP | 1999/04/07 | Manufacturing Change or Addition | 050065 | 035 | AP | 1999/02/05 | Manufacturing Change or Addition | 050065 | 034 | AP | 1998/05/29 | Manufacturing Change or Addition | 050065 | 032 | AP | 1996/11/29 | Control Supplement | 050065 | 031 | AP | 1996/03/18 | Control Supplement | 050065 | 030 | AP | 1995/05/18 | Formulation Revision | 050065 | 029 | AP | 1995/08/30 | Labeling Revision | 050065 | 028 | AP | 1983/07/11 | Control Supplement | 050065 | 027 | AP | 1982/07/29 | Labeling Revision | 050065 | 026 | AP | 1981/06/17 | Control Supplement | 050065 | 025 | AP | 1981/04/13 | Control Supplement | 050065 | 024 | AP | 1978/05/10 | Labeling Revision | 050065 | 023 | AP | 1973/02/20 | Control Supplement | 050065 | 022 | AP | 1973/02/08 | Control Supplement | 050065 | 021 | AP | 1973/02/08 | Control Supplement | 050065 | 020 | AP | 1972/09/19 | Labeling Revision | 050065 | 019 | AP | 1972/07/12 | Control Supplement | 050065 | 018 | AP | 1972/04/17 | Control Supplement | 050065 | 017 | AP | 1972/04/10 | Package Change | 050065 | 016 | AP | 1971/08/09 | Labeling Revision | 050065 | 015 | AP | 1971/07/22 | Labeling Revision | 050065 | 014 | AP | 1970/06/04 | Control Supplement | 050065 | 013 | AP | 1992/02/03 | Control Supplement | 050065 | 010 | AP | 1992/09/17 | Package Change | 050065 | 009 | AP | 1988/03/22 | Control Supplement | 050065 | 008 | AP | 1987/05/15 | Labeling Revision | 050065 | 007 | AP | 1987/06/30 | Labeling Revision | 050065 | 006 | AP | 1987/06/30 | Manufacturing Change or Addition | 050065 | 005 | AP | 1984/07/25 | Control Supplement | 050065 | 004 | AP | 1984/04/23 | Control Supplement | 050065 | 003 | AP | 1983/12/30 | Labeling Revision | 050065 | 002 | AP | 1983/11/23 | Control Supplement | 050065 | 001 | AP | 1983/07/11 | Control Supplement | 050065 | 000 | AP | 1963/07/19 | Approval |
|