药品名称 | DECLOMYCIN | 申请号 | 050261 | 产品号 | 002 | 活性成分 | DEMECLOCYCLINE HYDROCHLORIDE | 市场状态 | 停止上市 | 剂型或给药途径 | TABLET;ORAL | 规格 | 150MG | 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 | COREPHARMA LLC
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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 | 050261 | 101 | AP | Label | 2012/09/06 | 下载 | 050261 | 101 | AP | Letter | 2012/09/07 | 下载 | 050261 | 100 | AP | Letter | 2008/04/25 | 下载 | 050261 | 100 | AP | Label | 2008/06/05 | 下载 | 050261 | 097 | AP | Letter | 2003/12/22 | 下载 | 050261 | 095 | AP | Letter | 2003/05/30 | 下载 | 050261 | 094 | AP | Letter | 2003/12/22 | 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 | 050261 | 101 | AP | 2012/09/05 | Labeling Revision | 050261 | 100 | AP | 2008/04/22 | Labeling Revision | 050261 | 097 | AP | 2003/12/18 | Labeling Revision | 050261 | 095 | AP | 2003/05/01 | Labeling Revision | 050261 | 094 | AP | 2003/12/18 | Labeling Revision | 050261 | 093 | AP | 2000/12/07 | Control Supplement | 050261 | 092 | AP | 1999/10/20 | Control Supplement | 050261 | 091 | AP | 1997/06/25 | Manufacturing Change or Addition | 050261 | 090 | AP | 1997/06/25 | Package Change | 050261 | 089 | AP | 1982/03/26 | Package Change | 050261 | 088 | AP | 1980/04/08 | Control Supplement | 050261 | 087 | AP | 1979/05/16 | Control Supplement | 050261 | 086 | AP | 1978/09/20 | Formulation Revision | 050261 | 085 | AP | 1978/09/14 | Expiration Date Change | 050261 | 084 | AP | 1978/06/07 | Labeling Revision | 050261 | 083 | AP | 1976/08/25 | Control Supplement | 050261 | 082 | AP | 1976/06/25 | Expiration Date Change | 050261 | 081 | AP | 1976/03/22 | Control Supplement | 050261 | 080 | AP | 1975/12/29 | Control Supplement | 050261 | 079 | AP | 1975/07/08 | Control Supplement | 050261 | 078 | AP | 1974/04/25 | Expiration Date Change | 050261 | 077 | AP | 1974/02/28 | Labeling Revision | 050261 | 076 | AP | 1974/01/10 | Formulation Revision | 050261 | 075 | AP | 1973/10/01 | Labeling Revision | 050261 | 074 | AP | 1973/10/01 | Labeling Revision | 050261 | 073 | AP | 1973/10/01 | Labeling Revision | 050261 | 072 | AP | 1972/02/16 | Package Change | 050261 | 071 | AP | 1972/02/16 | Package Change | 050261 | 070 | AP | 1972/02/16 | Labeling Revision | 050261 | 069 | AP | 1972/01/10 | Labeling Revision | 050261 | 068 | AP | 1972/01/10 | Labeling Revision | 050261 | 067 | AP | 1972/01/10 | Labeling Revision | 050261 | 066 | AP | 1971/07/14 | Labeling Revision | 050261 | 065 | AP | 1971/06/14 | Formulation Revision | 050261 | 064 | AP | 1970/12/01 | Formulation Revision | 050261 | 063 | AP | 1970/10/23 | Expiration Date Change | 050261 | 062 | AP | 1970/10/23 | Expiration Date Change | 050261 | 061 | AP | 1970/04/14 | Formulation Revision | 050261 | 060 | AP | 1969/01/03 | Package Change | 050261 | 059 | AP | 1967/12/07 | Labeling Revision | 050261 | 058 | AP | 1967/11/17 | Labeling Revision | 050261 | 057 | AP | 1967/04/25 | Labeling Revision | 050261 | 056 | AP | 1967/04/25 | Labeling Revision | 050261 | 055 | AP | 1967/04/25 | Labeling Revision | 050261 | 054 | AP | 1967/02/15 | Labeling Revision | 050261 | 053 | AP | 1967/02/20 | Labeling Revision | 050261 | 052 | AP | 1966/12/29 | Package Change | 050261 | 051 | AP | 1966/12/29 | Package Change | 050261 | 050 | AP | 1966/11/29 | Labeling Revision | 050261 | 046 | AP | 1966/09/28 | Labeling Revision | 050261 | 045 | AP | 1966/09/28 | Labeling Revision | 050261 | 044 | AP | 1966/12/05 | Labeling Revision | 050261 | 043 | AP | 1966/09/15 | Formulation Revision | 050261 | 042 | AP | 1966/07/06 | Labeling Revision | 050261 | 041 | AP | 1966/06/03 | Labeling Revision | 050261 | 040 | AP | 1966/05/04 | Labeling Revision | 050261 | 039 | AP | 1966/05/04 | Labeling Revision | 050261 | 038 | AP | 1966/05/04 | Labeling Revision | 050261 | 037 | AP | 1966/05/04 | Labeling Revision | 050261 | 036 | AP | 1966/05/04 | Labeling Revision | 050261 | 035 | AP | 1966/05/04 | Labeling Revision | 050261 | 034 | AP | 1966/05/04 | Labeling Revision | 050261 | 033 | AP | 1966/05/04 | Labeling Revision | 050261 | 032 | AP | 1966/05/04 | Labeling Revision | 050261 | 031 | AP | 1966/05/04 | Labeling Revision | 050261 | 030 | AP | 1966/03/25 | Labeling Revision | 050261 | 029 | AP | 1966/03/11 | Labeling Revision | 050261 | 028 | AP | 1966/02/18 | Labeling Revision | 050261 | 027 | AP | 1966/03/14 | Labeling Revision | 050261 | 026 | AP | 1966/01/05 | Labeling Revision | 050261 | 025 | AP | 1966/01/05 | Labeling Revision | 050261 | 024 | AP | 1965/12/22 | Labeling Revision | 050261 | 023 | AP | 1966/01/13 | Labeling Revision | 050261 | 022 | AP | 1966/01/13 | Labeling Revision | 050261 | 021 | AP | 1965/12/07 | Labeling Revision | 050261 | 020 | AP | 1965/12/13 | Labeling Revision | 050261 | 019 | AP | 1965/12/23 | New Dosage Regimen | 050261 | 018 | AP | 1965/08/19 | Labeling Revision | 050261 | 017 | AP | 1965/09/24 | Package Change | 050261 | 016 | AP | 1965/05/14 | Manufacturing Change or Addition | 050261 | 015 | AP | 1965/05/14 | Manufacturing Change or Addition | 050261 | 014 | AP | 1965/03/11 | Labeling Revision | 050261 | 011 | AP | 1991/11/20 | Labeling Revision | 050261 | 006 | AP | 1987/12/17 | Formulation Revision | 050261 | 005 | AP | 1986/10/09 | Labeling Revision | 050261 | 003 | AP | 1965/02/10 | Labeling Revision | 050261 | 002 | AP | 1983/06/21 | Control Supplement | 050261 | 000 | AP | 1964/09/22 | Approval |
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