药品注册申请号:062311
申请类型:ANDA (仿制药申请)
申请人:APOTHECON
申请人全名:APOTHECON INC DIV BRISTOL MYERS SQUIBB
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 AMIKIN AMIKACIN SULFATE INJECTABLE;INJECTION EQ 50MG BASE/ML No No None 1981/01/22 Approved Prior to Jan 1, 1982 Discontinued
002 AMIKIN AMIKACIN SULFATE INJECTABLE;INJECTION EQ 250MG BASE/ML 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
2001/09/17 SUPPL-27(补充) Approval Manufacturing (CMC)
2000/05/30 SUPPL-26(补充) Approval Labeling
1996/07/31 SUPPL-25(补充) Approval Labeling
1993/11/16 SUPPL-23(补充) Approval Manufacturing (CMC)
1993/07/22 SUPPL-24(补充) Approval Labeling
1990/11/29 SUPPL-22(补充) Approval Manufacturing (CMC)
1988/02/19 SUPPL-21(补充) Approval Manufacturing (CMC)
1988/02/16 SUPPL-20(补充) Approval Manufacturing (CMC)
1985/05/09 SUPPL-12(补充) Approval Manufacturing (CMC)
1984/03/29 SUPPL-7(补充) Approval Manufacturing (CMC)
1983/10/12 SUPPL-6(补充) Approval Manufacturing (CMC)
1983/08/24 SUPPL-5(补充) Approval Manufacturing (CMC)
1983/08/17 SUPPL-4(补充) Approval Manufacturing (CMC)
1983/08/03 SUPPL-3(补充) Approval Manufacturing (CMC)
1983/02/22 SUPPL-2(补充) Approval Manufacturing (CMC)
1982/11/16 SUPPL-1(补充) Approval Manufacturing (CMC)
1981/01/22 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
更多信息
药品NDC数据与药品包装、标签说明书
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