药品注册申请号:009486
申请类型:NDA (新药申请)
申请人:MCNEIL CONS
申请人全名:MCNEIL CONSUMER HEALTHCARE
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 BENADRYL PRESERVATIVE FREE DIPHENHYDRAMINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1957/12/30 Approved Prior to Jan 1, 1982 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2003/10/24 SUPPL 28 Approval Labeling STANDARD
2001/12/14 SUPPL 27 Approval Manufacturing (CMC) STANDARD
2000/03/30 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1997/11/18 SUPPL 22 Approval Labeling STANDARD
1997/07/01 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1997/06/06 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1997/04/04 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1997/03/31 SUPPL 21 Approval Labeling STANDARD
1996/05/13 SUPPL 19 Approval Labeling STANDARD
1992/08/20 SUPPL 18 Approval Labeling STANDARD
1986/07/16 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1986/07/16 SUPPL 15 Approval Labeling STANDARD
1957/12/30 ORIG 1 Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
本品无治疗等效药品
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药品NDC数据与药品包装、标签说明书
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