药品注册申请号:074584
申请类型:ANDA (仿制药申请)
申请人:UPSHER SMITH LABS
申请人全名:UPSHER SMITH LABORATORIES LLC
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 BACLOFEN BACLOFEN TABLET;ORAL 10MG No No AB 1996/08/19 1996/08/19 Prescription
002 BACLOFEN BACLOFEN TABLET;ORAL 20MG No No AB 1996/08/19 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
2011/06/17 SUPPL 18 Approval Labeling
2005/09/20 SUPPL 4 Approval Labeling
1996/08/19 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:BACLOFEN 剂型/给药途径:TABLET;ORAL 规格:10MG 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
077089 001 BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No AB --
078504 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No AB -- NORTHSTAR HLTHCARE
072234 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 1988/07/21 IVAX SUB TEVA PHARMS
074584 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 1996/08/19 UPSHER SMITH LABS
077068 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2005/08/30 VINTAGE PHARMS
077241 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2007/07/06 LANNETT CO INC
077971 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2007/10/26 IMPAX LABS
077088 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2007/10/31 OXFORD PHARMS
078401 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2009/09/18 NORTHSTAR HLTHCARE
209102 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2017/11/28 RUBICON
211659 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2018/11/23 ZYDUS
211555 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2019/02/01 EYWA PHARMA
活性成分:BACLOFEN 剂型/给药途径:TABLET;ORAL 规格:20MG 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
072235 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No Yes AB 1988/07/21 IVAX SUB TEVA PHARMS
074584 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 1996/08/19 UPSHER SMITH LABS
077068 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2005/08/30 VINTAGE PHARMS
077241 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2005/12/20 LANNETT CO INC
077971 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2007/10/26 IMPAX LABS
077088 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2007/10/31 OXFORD PHARMS
078401 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2009/09/18 NORTHSTAR HLTHCARE
209102 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2017/11/28 RUBICON
211659 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2018/11/23 ZYDUS
211555 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2019/02/01 EYWA PHARMA
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