药品名称 | CLEOCIN HYDROCHLORIDE | 申请号 | 050162 | 产品号 | 003 | 活性成分 | CLINDAMYCIN HYDROCHLORIDE | 市场状态 | 处方药 | 剂型或给药途径 | CAPSULE;ORAL | 规格 | EQ 300MG BASE | 治疗等效代码 | AB | 参比药物 | 是 | 批准日期 | 1988/04/14 | 申请机构 | PHARMACIA AND UPJOHN CO
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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 |
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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 |
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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 | 050162 | 097 | AP | Letter | 2016/08/03 | 下载 | 050162 | 097 | AP | Label | 2016/08/09 | 下载 | 050162 | 096 | AP | Label | 2016/03/29 | 下载 | 050162 | 096 | AP | Letter | 2016/03/25 | 下载 | 050162 | 095 | AP | Label | 2016/03/29 | 下载 | 050162 | 095 | AP | Letter | 2016/03/25 | 下载 | 050162 | 093 | AP | Label | 2014/06/30 | 下载 | 050162 | 093 | AP | Letter | 2014/06/27 | 下载 | 050162 | 092 | AP | Label | 2014/06/30 | 下载 | 050162 | 092 | AP | Letter | 2014/06/27 | 下载 | 050162 | 090 | AP | Letter | 2011/06/10 | 下载 | 050162 | 085 | AP | Label | 2009/11/23 | 下载 | 050162 | 085 | AP | Letter | 2010/01/21 | 下载 | 050162 | 084 | AP | Letter | 2004/02/02 | 下载 | 050162 | 082 | AP | Letter | 2004/10/04 | 下载 | 050162 | 082 | AP | Label | 2004/10/04 | 下载 |
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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 | 050162 | 097 | AP | 2016/08/02 | Labeling Revision | 050162 | 096 | AP | 2016/03/23 | Labeling Revision | 050162 | 095 | AP | 2016/03/23 | Labeling Revision | 050162 | 094 | AP | 2016/01/21 | Manufacturing Change or Addition | 050162 | 093 | AP | 2014/06/26 | Labeling Revision | 050162 | 092 | AP | 2014/06/26 | Labeling Revision | 050162 | 090 | AP | 2011/06/07 | Labeling Revision | 050162 | 085 | AP | 2009/11/20 | Labeling Revision | 050162 | 084 | AP | 2004/01/28 | Labeling Revision | 050162 | 083 | AP | 1999/11/15 | Package Change | 050162 | 082 | AP | 2004/09/29 | Labeling Revision | 050162 | 081 | AP | 1998/02/24 | Package Change | 050162 | 080 | AP | 1997/12/12 | Labeling Revision | 050162 | 079 | AP | 1997/07/17 | Labeling Revision | 050162 | 077 | AP | 1982/04/27 | Formulation Revision | 050162 | 076 | AP | 1981/11/03 | New Dosage Regimen | 050162 | 075 | AP | 1981/05/20 | Control Supplement | 050162 | 074 | AP | 1980/05/27 | Control Supplement | 050162 | 073 | AP | 1980/04/30 | Labeling Revision | 050162 | 072 | AP | 1979/11/06 | Labeling Revision | 050162 | 071 | AP | 1979/07/20 | Manufacturing Change or Addition | 050162 | 070 | AP | 1979/07/09 | Labeling Revision | 050162 | 069 | AP | 1979/07/09 | Labeling Revision | 050162 | 068 | AP | 1979/05/18 | Control Supplement | 050162 | 067 | AP | 1979/04/24 | Labeling Revision | 050162 | 066 | AP | 1978/10/04 | Labeling Revision | 050162 | 064 | AP | 1979/06/28 | Labeling Revision | 050162 | 063 | AP | 1978/07/11 | Labeling Revision | 050162 | 062 | AP | 1978/02/14 | Control Supplement | 050162 | 061 | AP | 1977/01/03 | Labeling Revision | 050162 | 060 | AP | 1976/07/02 | Control Supplement | 050162 | 059 | AP | 1976/06/02 | Control Supplement | 050162 | 058 | AP | 1976/01/28 | Control Supplement | 050162 | 057 | AP | 1977/08/15 | Labeling Revision | 050162 | 056 | AP | 1975/11/17 | Labeling Revision | 050162 | 055 | AP | 1975/06/11 | Labeling Revision | 050162 | 054 | AP | 1975/03/17 | Labeling Revision | 050162 | 053 | AP | 1975/03/14 | Labeling Revision | 050162 | 052 | AP | 1974/08/09 | Labeling Revision | 050162 | 051 | AP | 1974/06/06 | Control Supplement | 050162 | 050 | AP | 1974/08/16 | Labeling Revision | 050162 | 048 | AP | 1973/11/06 | Control Supplement | 050162 | 047 | AP | 1973/10/16 | Labeling Revision | 050162 | 046 | AP | 1973/07/20 | Package Change | 050162 | 045 | AP | 1974/04/24 | Labeling Revision | 050162 | 044 | AP | 1974/04/24 | Labeling Revision | 050162 | 043 | AP | 1973/04/03 | Labeling Revision | 050162 | 042 | AP | 1973/07/19 | Labeling Revision | 050162 | 041 | AP | 1973/01/12 | Control Supplement | 050162 | 040 | AP | 1972/07/25 | Labeling Revision | 050162 | 038 | AP | 1972/07/14 | Control Supplement | 050162 | 037 | AP | 1972/08/10 | Labeling Revision | 050162 | 036 | AP | 1972/05/11 | Control Supplement | 050162 | 034 | AP | 1972/04/12 | Labeling Revision | 050162 | 033 | AP | 1972/02/15 | Labeling Revision | 050162 | 032 | AP | 1972/05/22 | Expiration Date Change | 050162 | 029 | AP | 1971/09/22 | Labeling Revision | 050162 | 028 | AP | 1971/06/14 | Control Supplement | 050162 | 027 | AP | 1972/02/15 | Labeling Revision | 050162 | 024 | AP | 1971/07/22 | Labeling Revision | 050162 | 022 | AP | 1997/03/17 | Labeling Revision | 050162 | 021 | AP | 1993/03/05 | Manufacturing Change or Addition | 050162 | 020 | AP | 1995/02/21 | Labeling Revision | 050162 | 019 | AP | 1971/02/19 | Labeling Revision | 050162 | 018 | AP | 1997/03/17 | Labeling Revision | 050162 | 017 | AP | 1971/05/18 | Labeling Revision | 050162 | 016 | AP | 1970/12/18 | Labeling Revision | 050162 | 015 | AP | 1970/12/15 | Labeling Revision | 050162 | 014 | AP | 1970/12/09 | Labeling Revision | 050162 | 013 | AP | 1970/11/16 | Labeling Revision | 050162 | 012 | AP | 1971/04/26 | Labeling Revision | 050162 | 011 | AP | 1988/04/14 | New Dosage Regimen | 050162 | 010 | AP | 1986/10/20 | Labeling Revision | 050162 | 009 | AP | 1997/03/17 | Labeling Revision | 050162 | 007 | AP | 1985/06/21 | Labeling Revision | 050162 | 006 | AP | 1970/09/21 | Control Supplement | 050162 | 005 | AP | 1985/09/10 | Labeling Revision | 050162 | 004 | AP | 1983/04/29 | Package Change | 050162 | 003 | AP | 1970/07/01 | Control Supplement | 050162 | 001 | AP | 1970/05/22 | New or Modified Indication | 050162 | 000 | AP | 1970/02/22 | Approval |
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