药品注册申请号:050072
申请类型:NDA (新药申请)
申请人:WYETH AYERST
申请人全名:WYETH AYERST LABORATORIES
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 PENBRITIN-S AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 125MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1966/12/29 Approved Prior to Jan 1, 1982 Discontinued
002 PENBRITIN-S AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 PENBRITIN-S AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 PENBRITIN-S AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 PENBRITIN-S AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
006 PENBRITIN-S AMPICILLIN SODIUM INJECTABLE;INJECTION EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
1977/11/29 SUPPL 3 Approval Labeling
1966/12/29 ORIG 1 Approval UNKNOWN
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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