药品注册申请号:050339
申请类型:NDA (新药申请)
申请人:PHARMACIA AND UPJOHN
申请人全名:--
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 ALBAMYCIN NOVOBIOCIN SODIUM CAPSULE; ORAL EQ 250MG BASE No None 1964/09/04 -- 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
1983/02/17 SUPPL 1 Approval Manufacturing (CMC)
1982/08/24 SUPPL 37 Approval Manufacturing (CMC)
1982/06/24 SUPPL 36 Approval Labeling
1982/02/22 SUPPL 35 Approval Manufacturing (CMC)
1979/04/27 SUPPL 34 Approval Labeling
1979/04/03 SUPPL 33 Approval Manufacturing (CMC)
1978/03/24 SUPPL 32 Approval Manufacturing (CMC)
1976/11/24 SUPPL 31 Approval Manufacturing (CMC)
1975/04/01 SUPPL 30 Approval Manufacturing (CMC)
1974/11/26 SUPPL 29 Approval Labeling
1973/06/08 SUPPL 28 Approval Manufacturing (CMC)
1973/06/08 SUPPL 27 Approval Labeling
1972/05/04 SUPPL 26 Approval Labeling
1971/12/17 SUPPL 25 Approval Labeling
1970/10/12 SUPPL 24 Approval Manufacturing (CMC)
1970/07/21 SUPPL 23 Approval Labeling
1970/04/20 SUPPL 22 Approval Labeling
1970/03/27 SUPPL 21 Approval Labeling
1970/03/27 SUPPL 19 Approval Manufacturing (CMC)
1970/02/10 SUPPL 20 Approval Manufacturing (CMC)
1969/11/26 SUPPL 18 Approval Labeling
1969/11/14 SUPPL 17 Approval Manufacturing (CMC)
1969/10/06 SUPPL 16 Approval Labeling
1969/08/05 SUPPL 14 Approval Labeling
1969/06/30 SUPPL 15 Approval Labeling
1969/06/05 SUPPL 13 Approval Manufacturing (CMC)
1969/03/14 SUPPL 12 Approval Manufacturing (CMC)
1968/08/08 SUPPL 11 Approval Manufacturing (CMC)
1967/08/07 SUPPL 10 Approval Labeling
1967/03/20 SUPPL 9 Approval Labeling
1966/12/15 SUPPL 8 Approval Labeling
1966/11/25 SUPPL 7 Approval Manufacturing (CMC)
1966/09/19 SUPPL 6 Approval Labeling
1966/02/25 SUPPL 5 Approval Labeling
1965/01/22 SUPPL 4 Approval Labeling
1964/11/06 SUPPL 3 Approval Labeling
1964/10/08 SUPPL 2 Approval Manufacturing (CMC)
1964/09/04 ORIG 1 Approval UNKNOWN
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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