药品注册申请号:085272
申请类型:ANDA (仿制药申请)
申请人:VALEANT
申请人全名:VALEANT PHARMACEUTICALS INTERNATIONAL
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 BONTRIL PDM PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG No Yes AA 1976/12/22 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
2008/01/16 SUPPL 44 Approval Labeling
2001/12/06 SUPPL 41 Approval Manufacturing (CMC)
2001/08/15 SUPPL 40 Approval Manufacturing (CMC)
2000/08/29 SUPPL 39 Approval Manufacturing (CMC)
1997/06/27 SUPPL 38 Approval Manufacturing (CMC)
1994/09/29 SUPPL 37 Approval Manufacturing (CMC)
1991/12/04 SUPPL 36 Approval Labeling
1991/11/18 SUPPL 35 Approval Manufacturing (CMC)
1991/04/26 SUPPL 34 Approval Labeling
1990/07/18 SUPPL 33 Approval Manufacturing (CMC)
1990/07/18 SUPPL 32 Approval Manufacturing (CMC)
1988/10/05 SUPPL 31 Approval Manufacturing (CMC)
1988/10/05 SUPPL 30 Approval Manufacturing (CMC)
1988/01/20 SUPPL 29 Approval Manufacturing (CMC)
1985/07/17 SUPPL 27 Approval Manufacturing (CMC)
1985/07/17 SUPPL 26 Approval Manufacturing (CMC)
1985/07/17 SUPPL 24 Approval Manufacturing (CMC)
1984/10/11 SUPPL 23 Approval Manufacturing (CMC)
1983/08/16 SUPPL 22 Approval Manufacturing (CMC)
1983/05/18 SUPPL 21 Approval Manufacturing (CMC)
1976/12/22 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:PHENDIMETRAZINE TARTRATE 剂型/给药途径:TABLET;ORAL 规格:35MG 治疗等效代码:AA
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
085272 001 ANDA BONTRIL PDM PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG Prescription No Yes AA Approved Prior to Jan 1, 1982 VALEANT
085588 001 ANDA PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG Prescription No No AA Approved Prior to Jan 1, 1982 VIRTUS PHARMS
089452 001 ANDA PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG Prescription No No AA 1991/10/30 MIKART
040762 001 ANDA PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG Prescription No No AA 2008/01/28 ELITE LABS INC
091042 001 ANDA PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG Prescription No No AA 2010/08/31 KVK TECH
203600 001 ANDA PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG Prescription No No AA 2017/12/27 NOSTRUM LABS INC
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2020 DrugFuture->U.S. FDA Drugs Database