药品注册申请号：022462
申请类型：NDA (新药申请)
申请人：PIRAMAL CRITICAL
申请人全名：PIRAMAL CRITICAL CARE 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 GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.05MG/ML Yes Yes AP 2010/11/19 2010/11/19 Prescription
002 GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Yes Yes AP 2010/11/19 Prescription
003 GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Yes Yes AP 2010/11/19 Prescription
004 GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 1MG/ML Yes Yes AP 2012/06/22 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
2022/05/31 SUPPL-15（补充） Approval Labeling STANDARD
2021/04/19 SUPPL-13（补充） Approval Labeling STANDARD
2019/12/19 SUPPL-11（补充） Approval Labeling STANDARD
2015/02/11 SUPPL-8（补充） Approval Labeling STANDARD
2013/01/17 SUPPL-4（补充） Approval Manufacturing (CMC) STANDARD
2012/06/22 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2010/11/19 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
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:INJECTABLE;INTRATHECAL 规格:0.05MG/ML 治疗等效代码:AP
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
020075 003 NDA LIORESAL BACLOFEN INJECTABLE;INTRATHECAL 0.05MG/ML Prescription Yes Yes AP 1996/11/07 AMNEAL
022462 001 NDA GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.05MG/ML Prescription Yes Yes AP 2010/11/19 PIRAMAL CRITICAL
091193 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.05MG/ML Prescription No No AP 2016/05/03 AMNEAL
210777 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.05MG/ML Prescription No No AP 2021/01/15 MAIA PHARMS INC
活性成分:BACLOFEN 剂型/给药途径:INJECTABLE;INTRATHECAL 规格:0.5MG/ML 治疗等效代码:AP
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
020075 001 NDA LIORESAL BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Prescription Yes Yes AP 1992/06/17 AMNEAL
022462 002 NDA GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Prescription Yes Yes AP 2010/11/19 PIRAMAL CRITICAL
091193 002 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Prescription No No AP 2016/05/03 AMNEAL
209592 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Prescription No No AP 2018/03/21 MYLAN LABS LTD
210048 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Prescription No No AP 2019/09/11 MAIA PHARMS INC
217324 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Prescription No No AP 2023/02/22 RUBICON
216309 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 0.5MG/ML Discontinued No No AP 2023/08/10 HERITAGE
活性成分:BACLOFEN 剂型/给药途径:INJECTABLE;INTRATHECAL 规格:2MG/ML 治疗等效代码:AP
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
020075 002 NDA LIORESAL BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Prescription Yes Yes AP 1992/06/17 AMNEAL
022462 003 NDA GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Prescription Yes Yes AP 2010/11/19 PIRAMAL CRITICAL
091193 003 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Prescription No No AP 2016/05/03 AMNEAL
209592 002 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Prescription No No AP 2018/03/21 MYLAN LABS LTD
210048 002 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Prescription No No AP 2019/09/11 MAIA PHARMS INC
217324 003 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Prescription No No AP 2023/02/22 RUBICON
216309 002 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 2MG/ML Discontinued No No AP 2023/08/10 HERITAGE
活性成分:BACLOFEN 剂型/给药途径:INJECTABLE;INTRATHECAL 规格:1MG/ML 治疗等效代码:AP
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
022462 004 NDA GABLOFEN BACLOFEN INJECTABLE;INTRATHECAL 1MG/ML Prescription Yes Yes AP 2012/06/22 PIRAMAL CRITICAL
209594 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 1MG/ML Prescription No No AP 2018/03/06 MYLAN LABS LTD
210315 001 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 1MG/ML Prescription No No AP 2019/07/30 MAIA PHARMS INC
217324 002 ANDA BACLOFEN BACLOFEN INJECTABLE;INTRATHECAL 1MG/ML Prescription No No AP 2023/02/22 RUBICON
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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