| 药品名称 | DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | | 申请号 | 086727 | 产品号 | 001 | | 活性成分 | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE | 市场状态 | 停止上市 | | 剂型或给药途径 | TABLET;ORAL | 规格 | 0.025MG;2.5MG | | 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 | ANI PHARMACEUTICALS INC
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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 | | 无 |
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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 | | 086727 | 044 | AP | 2007/06/19 | Facility Addition | | 086727 | 038 | AP | 2002/07/29 | Facility Addition | | 086727 | 036 | AP | 2001/09/12 | Packager Addition | | 086727 | 035 | AP | 2000/08/15 | Facility Addition | | 086727 | 034 | AP | 2000/05/05 | Labeling | | 086727 | 033 | AP | 2000/05/05 | Package Change | | 086727 | 032 | AP | 2000/05/05 | Facility Addition | | 086727 | 031 | AP | 2000/01/28 | Facility Addition | | 086727 | 030 | AP | 1999/11/18 | Facility Addition | | 086727 | 029 | AP | 1999/11/18 | Control Supplement | | 086727 | 028 | AP | 1999/11/18 | Facility Addition | | 086727 | 027 | AP | 1999/03/12 | Chemistry | | 086727 | 026 | AP | 1998/09/24 | Labeling | | 086727 | 025 | AP | 1988/01/20 | Chemistry | | 086727 | 024 | AP | 1988/01/20 | Chemistry | | 086727 | 020 | AP | 1987/01/14 | Chemistry | | 086727 | 019 | AP | 1987/01/14 | Chemistry | | 086727 | 000 | AP | 1979/10/29 | Approval |
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