药品注册申请号：211659
申请类型：ANDA (仿制药申请)
申请人：ZYDUS LIFESCIENCES
申请人全名：ZYDUS LIFESCIENCES GLOBAL FZE
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 2018/11/23 2018/11/23 Prescription
002 BACLOFEN BACLOFEN TABLET;ORAL 20MG No No AB 2018/11/23 Prescription
003 BACLOFEN BACLOFEN TABLET;ORAL 5MG No No AB 2020/04/17 Prescription
004 BACLOFEN BACLOFEN TABLET;ORAL 15MG No No AB 2024/02/13 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2018/11/23 ORIG-1（原始申请） Approval STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
无
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
无
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
无
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 No AB --
078504 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No 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 YILING
077068 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2005/08/30 PH HEALTH
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 Discontinued No No AB 2007/10/26 IMPAX
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 RESEARCH
211659 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2018/11/23 ZYDUS LIFESCIENCES
212067 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2020/07/09 UNICHEM
212378 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2020/10/09 ANDAS 5 HOLDING
214374 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2021/03/05 RISING
214099 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2021/07/13 AUROBINDO PHARMA LTD
214114 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2021/07/16 REGCON HOLDINGS
215885 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2022/01/25 MANKIND PHARMA
217687 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2023/11/08 MICRO LABS
217788 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 10MG Prescription No No AB 2024/01/10 RISING
>>>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 YILING
077068 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2005/08/30 PH HEALTH
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 Discontinued No No AB 2007/10/26 IMPAX
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 RESEARCH
211659 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2018/11/23 ZYDUS LIFESCIENCES
212067 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2020/07/09 UNICHEM
212378 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2020/10/09 ANDAS 5 HOLDING
214374 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2021/03/05 RISING
214099 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2021/07/13 AUROBINDO PHARMA LTD
214114 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2021/07/16 REGCON HOLDINGS
215885 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2022/01/25 MANKIND PHARMA
217687 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2023/11/08 MICRO LABS
217788 002 ANDA BACLOFEN BACLOFEN TABLET;ORAL 20MG Prescription No No AB 2024/01/10 RISING
>>>活性成分:BACLOFEN; 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
214099 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB -- AUROBINDO PHARMA LTD
209102 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No Yes AB 2017/11/28 RUBICON RESEARCH
211659 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2020/04/17 ZYDUS LIFESCIENCES
214374 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2021/03/05 RISING
212378 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2021/04/30 ANDAS 5 HOLDING
077971 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Discontinued No No AB 2021/07/07 IMPAX
077241 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2021/09/22 LANNETT CO INC
215885 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2022/01/25 MANKIND PHARMA
212067 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2023/03/09 UNICHEM
214114 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2023/09/19 REGCON HOLDINGS
217687 001 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2023/11/08 MICRO LABS
217788 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2024/10/24 RISING
090334 003 ANDA BACLOFEN BACLOFEN TABLET;ORAL 5MG Prescription No No AB 2025/01/31 APPCO
>>>活性成分:BACLOFEN; 剂型/给药途径:TABLET;ORAL; 规格:15MG; 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
209102 004 ANDA BACLOFEN BACLOFEN TABLET;ORAL 15MG Prescription No No AB 2024/02/05 RUBICON RESEARCH
211659 004 ANDA BACLOFEN BACLOFEN TABLET;ORAL 15MG Prescription No No AB 2024/02/13 ZYDUS LIFESCIENCES
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药品NDC数据与药品包装、标签说明书
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