药品注册申请号:080832
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 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG No No None 1972/11/03 Approved Prior to Jan 1, 1982 Discontinued
002 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG 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
1997/04/07 SUPPL-105(补充) Approval Manufacturing (CMC)
1995/01/10 SUPPL-104(补充) Approval Manufacturing (CMC)
1990/11/05 SUPPL-103(补充) Approval Labeling
1990/05/21 SUPPL-102(补充) Approval Labeling
1989/11/02 SUPPL-101(补充) Approval Labeling
1989/10/18 SUPPL-100(补充) Approval Labeling
1987/02/02 SUPPL-99(补充) Approval Manufacturing (CMC)
1987/02/02 SUPPL-98(补充) Approval Manufacturing (CMC)
1985/10/01 SUPPL-96(补充) Approval Manufacturing (CMC)
1985/07/08 SUPPL-95(补充) Approval Manufacturing (CMC)
1985/03/22 SUPPL-93(补充) Approval Manufacturing (CMC)
1984/08/22 SUPPL-91(补充) Approval Manufacturing (CMC)
1984/02/07 SUPPL-89(补充) Approval Manufacturing (CMC)
1983/07/12 SUPPL-88(补充) Approval Manufacturing (CMC)
1983/07/12 SUPPL-87(补充) Approval Manufacturing (CMC)
1983/05/23 SUPPL-85(补充) Approval Manufacturing (CMC)
1982/08/05 SUPPL-82(补充) Approval Manufacturing (CMC)
1972/11/03 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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