药品注册申请号:061461
申请类型:ANDA (仿制药申请)
申请人:ANI PHARMS INC
申请人全名:ANI PHARMACEUTICALS INC
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 ERYTHROMYCIN STEARATE ERYTHROMYCIN STEARATE TABLET;ORAL EQ 250MG BASE No No None 1980/04/11 Approved Prior to Jan 1, 1982 Discontinued
002 ERYTHROMYCIN STEARATE ERYTHROMYCIN STEARATE TABLET;ORAL EQ 500MG BASE No 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
1999/08/20 SUPPL 26 Approval Manufacturing (CMC)
1998/12/09 SUPPL 25 Approval Manufacturing (CMC)
1997/05/30 SUPPL 24 Approval Manufacturing (CMC)
1993/07/01 SUPPL 23 Approval Labeling
1993/05/14 SUPPL 22 Approval Labeling
1993/03/23 SUPPL 21 Approval Manufacturing (CMC)
1993/03/23 SUPPL 20 Approval Manufacturing (CMC)
1992/09/03 SUPPL 19 Approval Manufacturing (CMC)
1992/08/20 SUPPL 17 Approval Manufacturing (CMC)
1992/08/20 SUPPL 16 Approval Labeling
1992/06/23 SUPPL 15 Approval Manufacturing (CMC)
1988/09/26 SUPPL 14 Approval Manufacturing (CMC)
1980/04/11 ORIG 1 Approval
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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