药品注册申请号:088134
申请类型:ANDA (仿制药申请)
申请人:FOSUN PHARMA
申请人全名:FOSUN PHARMA USA 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 THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE TABLET;ORAL 50MG No No None 1983/08/30 1983/08/30 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
2017/02/23 SUPPL 47 Approval Labeling STANDARD
2016/04/19 SUPPL 46 Approval Labeling
2002/12/16 SUPPL 42 Approval Manufacturing (CMC)
2002/09/05 SUPPL 41 Approval Labeling
2001/08/14 SUPPL 39 Approval Labeling
2001/02/21 SUPPL 40 Approval Manufacturing (CMC)
1999/05/05 SUPPL 37 Approval Manufacturing (CMC)
1998/10/20 SUPPL 35 Approval Labeling
1998/10/20 SUPPL 34 Approval Manufacturing (CMC)
1998/09/18 SUPPL 36 Approval Manufacturing (CMC)
1995/03/21 SUPPL 33 Approval Manufacturing (CMC)
1990/01/09 SUPPL 32 Approval Labeling
1989/09/28 SUPPL 31 Approval Labeling
1988/11/10 SUPPL 30 Approval Manufacturing (CMC)
1987/03/18 SUPPL 27 Approval Manufacturing (CMC)
1986/11/13 SUPPL 21 Approval Manufacturing (CMC)
1986/11/13 SUPPL 20 Approval Manufacturing (CMC)
1986/11/13 SUPPL 19 Approval Manufacturing (CMC)
1986/08/29 SUPPL 23 Approval Manufacturing (CMC)
1986/04/18 SUPPL 24 Approval Manufacturing (CMC)
1986/04/18 SUPPL 16 Approval Manufacturing (CMC)
1984/10/23 SUPPL 15 Approval Manufacturing (CMC)
1984/10/23 SUPPL 7 Approval Manufacturing (CMC)
1984/10/23 SUPPL 6 Approval Manufacturing (CMC)
1984/10/23 SUPPL 5 Approval Manufacturing (CMC)
1984/10/23 SUPPL 4 Approval Manufacturing (CMC)
1984/06/28 SUPPL 1 Approval Manufacturing (CMC)
1983/08/30 ORIG 1 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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