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 Yes Yes AA 1976/12/22 Approved Prior to Jan 1, 1982 Prescription
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
2008/01/16 SUPPL-44(补充) Approval Labeling
2001/12/06 SUPPL-41(补充) Approval Manufacturing (CMC)
2001/08/15 SUPPL-40(补充) Approval Manufacturing (CMC)
2000/08/29 SUPPL-39(补充) Approval Manufacturing (CMC)
1997/06/27 SUPPL-38(补充) Approval Manufacturing (CMC)
1994/09/29 SUPPL-37(补充) Approval Manufacturing (CMC)
1991/12/04 SUPPL-36(补充) Approval Labeling
1991/11/18 SUPPL-35(补充) Approval Manufacturing (CMC)
1991/04/26 SUPPL-34(补充) Approval Labeling
1990/07/18 SUPPL-33(补充) Approval Manufacturing (CMC)
1990/07/18 SUPPL-32(补充) Approval Manufacturing (CMC)
1988/10/05 SUPPL-31(补充) Approval Manufacturing (CMC)
1988/10/05 SUPPL-30(补充) Approval Manufacturing (CMC)
1988/01/20 SUPPL-29(补充) Approval Manufacturing (CMC)
1985/07/17 SUPPL-27(补充) Approval Manufacturing (CMC)
1985/07/17 SUPPL-26(补充) Approval Manufacturing (CMC)
1985/07/17 SUPPL-24(补充) Approval Manufacturing (CMC)
1984/10/11 SUPPL-23(补充) Approval Manufacturing (CMC)
1983/08/16 SUPPL-22(补充) Approval Manufacturing (CMC)
1983/05/18 SUPPL-21(补充) Approval Manufacturing (CMC)
1976/12/22 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)
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 Yes 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
089452 001 ANDA PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE TABLET;ORAL 35MG Prescription No No AA 1991/10/30 CHARTWELL
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
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