药品注册申请号:211149
申请类型:ANDA (仿制药申请)
申请人:TEVA PHARMS USA
申请人全名:TEVA PHARMACEUTICALS USA 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 PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 39MG/0.25ML (39MG/0.25ML) No No AB 2021/07/06 2021/07/06 Prescription
002 PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 78MG/0.5ML (78MG/0.5ML) No No AB 2021/07/06 Prescription
003 PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 117MG/0.75ML (117MG/0.75ML) No No AB 2021/07/06 Prescription
004 PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 156MG/ML (156MG/ML) No No AB 2021/07/06 Prescription
005 PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 234MG/1.5ML (156MG/ML) No No AB 2021/07/06 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
2021/07/06 ORIG-1(原始申请) Approval 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
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:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:39MG/0.25ML (39MG/0.25ML) 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
022264 001 NDA INVEGA SUSTENNA PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 39MG/0.25ML (39MG/0.25ML) Prescription Yes No AB 2009/07/31 JANSSEN PHARMS
211149 001 ANDA PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 39MG/0.25ML (39MG/0.25ML) Prescription No No AB 2021/07/06 TEVA PHARMS USA
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:78MG/0.5ML (78MG/0.5ML) 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
022264 002 NDA INVEGA SUSTENNA PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 78MG/0.5ML (78MG/0.5ML) Prescription Yes No AB 2009/07/31 JANSSEN PHARMS
211149 002 ANDA PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 78MG/0.5ML (78MG/0.5ML) Prescription No No AB 2021/07/06 TEVA PHARMS USA
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:117MG/0.75ML (117MG/0.75ML) 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
022264 003 NDA INVEGA SUSTENNA PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 117MG/0.75ML (117MG/0.75ML) Prescription Yes No AB 2009/07/31 JANSSEN PHARMS
211149 003 ANDA PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 117MG/0.75ML (117MG/0.75ML) Prescription No No AB 2021/07/06 TEVA PHARMS USA
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:156MG/ML (156MG/ML) 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
022264 004 NDA INVEGA SUSTENNA PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 156MG/ML (156MG/ML) Prescription Yes Yes AB 2009/07/31 JANSSEN PHARMS
211149 004 ANDA PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 156MG/ML (156MG/ML) Prescription No No AB 2021/07/06 TEVA PHARMS USA
活性成分:PALIPERIDONE PALMITATE 剂型/给药途径:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 规格:234MG/1.5ML (156MG/ML) 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
022264 005 NDA INVEGA SUSTENNA PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 234MG/1.5ML (156MG/ML) Prescription Yes No AB 2009/07/31 JANSSEN PHARMS
211149 005 ANDA PALIPERIDONE PALMITATE PALIPERIDONE PALMITATE SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 234MG/1.5ML (156MG/ML) Prescription No No AB 2021/07/06 TEVA PHARMS USA
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