药品注册申请号:061639
申请类型:ANDA (仿制药申请)
申请人:ARBOR PHARMS LLC
申请人全名:ARBOR PHARMACEUTICALS LLC
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 E.E.S. 200 ERYTHROMYCIN ETHYLSUCCINATE SUSPENSION;ORAL EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None 1973/10/15 Approved Prior to Jan 1, 1982 Discontinued
002 E.E.S. 400 ERYTHROMYCIN ETHYLSUCCINATE SUSPENSION;ORAL EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No None Approved Prior to Jan 1, 1982 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2015/09/01 SUPPL-33(补充) Approval Labeling STANDARD
2013/10/31 SUPPL-32(补充) Approval Labeling STANDARD
2009/02/25 SUPPL-29(补充) Approval Labeling
2009/02/25 SUPPL-28(补充) Approval Labeling
2006/07/21 SUPPL-26(补充) Approval Labeling
2001/01/17 SUPPL-23(补充) Approval Labeling
2000/11/16 SUPPL-22(补充) Approval Labeling
1997/11/28 SUPPL-21(补充) Approval Manufacturing (CMC)
1991/09/26 SUPPL-19(补充) Approval Manufacturing (CMC)
1973/10/15 ORIG-1(原始申请) Approval
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
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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