药品注册申请号:080352
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS 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 PREDNISONE PREDNISONE TABLET;ORAL 5MG No Yes AB 1972/04/21 Approved Prior to Jan 1, 1982 Prescription
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
2008/11/24 SUPPL 63 Approval Labeling
1997/06/09 SUPPL 51 Approval Manufacturing (CMC)
1997/06/09 SUPPL 50 Approval Manufacturing (CMC)
1997/06/09 SUPPL 48 Approval Manufacturing (CMC)
1997/06/09 SUPPL 47 Approval Manufacturing (CMC)
1997/03/11 SUPPL 53 Approval Manufacturing (CMC)
1996/08/28 SUPPL 52 Approval Manufacturing (CMC)
1995/07/13 SUPPL 49 Approval Labeling
1995/02/22 SUPPL 46 Approval Labeling
1994/10/07 SUPPL 45 Approval Labeling
1994/03/30 SUPPL 43 Approval Labeling
1991/06/07 SUPPL 42 Approval Labeling
1991/05/15 SUPPL 41 Approval Labeling
1989/12/26 SUPPL 39 Approval Labeling
1989/10/13 SUPPL 38 Approval Labeling
1988/09/22 SUPPL 37 Approval Manufacturing (CMC)
1988/09/22 SUPPL 36 Approval Manufacturing (CMC)
1988/09/02 SUPPL 31 Approval Bioequivalence
1984/02/21 SUPPL 30 Approval Manufacturing (CMC)
1982/04/06 SUPPL 28 Approval Manufacturing (CMC)
1972/04/21 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
活性成分:PREDNISONE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
080292 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB Approved Prior to Jan 1, 1982 MYLAN
080352 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No Yes AB Approved Prior to Jan 1, 1982 HIKMA
080356 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
089247 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 1985/12/04 SUN PHARM INDUSTRIES
040362 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2001/08/29 JUBILANT CADISTA
040256 001 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2002/07/12 VINTAGE PHARMS
211495 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2018/12/07 GENEYORK PHARMS
211575 002 ANDA PREDNISONE PREDNISONE TABLET;ORAL 5MG Prescription No No AB 2019/11/15 NOVITIUM PHARMA
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药品NDC数据与药品包装、标签说明书
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