药品注册申请号:062337
申请类型:ANDA (仿制药申请)
申请人:MYLAN
申请人全名:MYLAN 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 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 50MG BASE No No None 1982/03/29 1982/03/29 Discontinued
002 DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 100MG BASE No No None 1982/03/29 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
2015/06/30 SUPPL 25 Approval Labeling STANDARD
2014/09/02 SUPPL 24 Approval Labeling STANDARD
2002/12/23 SUPPL 23 Approval Labeling
1998/02/25 SUPPL 21 Approval Manufacturing (CMC)
1998/02/05 SUPPL 22 Approval Manufacturing (CMC)
1993/10/22 SUPPL 20 Approval Manufacturing (CMC)
1993/10/22 SUPPL 19 Approval Manufacturing (CMC)
1993/06/01 SUPPL 17 Approval Labeling
1992/12/16 SUPPL 16 Approval Labeling
1992/05/12 SUPPL 15 Approval Labeling
1992/05/12 SUPPL 14 Approval Labeling
1990/01/31 SUPPL 13 Approval Manufacturing (CMC)
1990/01/31 SUPPL 12 Approval Manufacturing (CMC)
1989/04/25 SUPPL 11 Approval Manufacturing (CMC)
1982/03/29 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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药品NDC数据与药品包装、标签说明书
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