药品注册申请号:062413
申请类型:ANDA (仿制药申请)
申请人:ABBOTT
申请人全名:ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
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 GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.2MG BASE/ML No No None 1983/08/11 1983/08/11 Discontinued
002 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.4MG BASE/ML No No None 1983/08/11 Discontinued
003 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.6MG BASE/ML No No None 1983/08/11 Discontinued
004 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 1.8MG BASE/ML No No None 1983/08/11 Discontinued
005 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 2MG BASE/ML No No None 1983/08/11 Discontinued
006 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 60MG BASE/100ML No No None 1983/08/11 Discontinued
007 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 70MG BASE/100ML No No None 1983/08/11 Discontinued
008 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 80MG BASE/100ML No No None 1983/08/11 Discontinued
009 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 90MG BASE/100ML No No None 1983/08/11 Discontinued
010 GENTAMICIN SULFATE GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 100MG BASE/100ML No No None 1983/08/11 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
1993/07/14 SUPPL-6(补充) Approval Labeling
1983/08/11 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
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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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