药品注册申请号：062814
申请类型：ANDA (仿制药申请)
申请人：B BRAUN
申请人全名：B BRAUN MEDICAL 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 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 0.8MG BASE/ML No No None 1987/08/28 1987/08/28 Discontinued
002 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.2MG BASE/ML No No None 1987/08/28 Discontinued
003 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.4MG BASE/ML No No None 1987/08/28 Discontinued
004 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.6MG BASE/ML No No None 1987/08/28 Discontinued
005 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.8MG BASE/ML No No None 1987/08/28 Discontinued
006 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 2MG BASE/ML No No None 1987/08/28 Discontinued
007 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 2.4MG BASE/ML No No None 1987/08/28 Discontinued
008 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 40MG BASE/100ML No No None 1987/08/28 Discontinued
009 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 60MG BASE/100ML No No None 1987/08/28 Discontinued
010 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 70MG BASE/100ML No No None 1987/08/28 Discontinued
011 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 80MG BASE/100ML No No None 1987/08/28 Discontinued
012 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 90MG BASE/100ML No No None 1987/08/28 Discontinued
013 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 100MG BASE/100ML No No None 1987/08/28 Discontinued
014 GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 120MG BASE/100ML No No None 1987/08/28 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1987/08/28 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2010/05/13 SUPPL-21（补充） Approval Labeling-Container/Carton Labels
2009/11/30 SUPPL-18（补充） Approval Labeling
2008/11/20 SUPPL-17（补充） Approval Labeling
2007/09/12 SUPPL-16（补充） Approval Labeling
2006/12/07 SUPPL-15（补充） Approval Labeling
2005/06/07 SUPPL-13（补充） Approval Labeling
2004/08/31 SUPPL-12（补充） Approval Labeling
2001/08/21 SUPPL-10（补充） Approval Manufacturing (CMC)
2001/08/03 SUPPL-9（补充） Approval Manufacturing (CMC)
1997/05/16 SUPPL-8（补充） Approval Manufacturing (CMC)
1996/03/01 SUPPL-7（补充） Approval Manufacturing (CMC)
1992/11/18 SUPPL-5（补充） Approval Labeling
1992/01/29 SUPPL-4（补充） Approval Manufacturing (CMC)
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
无
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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