药品注册申请号：206943
申请类型：ANDA (仿制药申请)
申请人：STRIDES PHARMA
申请人全名：STRIDES PHARMA GLOBAL PTE LTD
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 GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG No No AB 2018/05/14 2018/05/14 Prescription
002 GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG No No AB 2018/05/14 Prescription
003 GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG No No AB 2018/05/14 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
2018/05/14 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
2024/12/19 SUPPL-22（补充） Approval Labeling-Container/Carton Labels,Labeling-Medication Guide STANDARD
2024/12/19 SUPPL-21（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2024/12/19 SUPPL-12（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert STANDARD
2020/09/16 SUPPL-4（补充） Approval Labeling-Package Insert STANDARD
2020/09/16 SUPPL-1（补充） Approval Labeling-Package Insert 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:GABAPENTIN; 剂型/给药途径:CAPSULE;ORAL; 规格:100MG; 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
020235 001 NDA NEURONTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription Yes No AB 1993/12/30 VIATRIS
075350 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2003/09/12 ACTAVIS ELIZABETH
075477 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2005/03/23 CSPC OUYI
075360 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2005/04/06 GRANULES
077242 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Discontinued No No AB 2006/08/24 SUN PHARM INDS LTD
078428 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2007/07/25 AMNEAL PHARMS NY
078787 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2008/01/31 AUROBINDO PHARMA
090705 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2009/12/30 INVAGEN PHARMS
090858 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2010/12/17 ALKEM
090007 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2011/07/21 MARKSANS PHARMA
077261 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Discontinued No No AB 2013/08/02 TARO
204989 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2016/02/18 SCIEGEN PHARMS INC
207099 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2017/03/24 RISING
206943 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2018/05/14 STRIDES PHARMA
211314 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2018/10/16 STRIDES PHARMA
213603 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2020/08/17 ZHEJIANG YONGTAI
214956 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2021/05/10 ASCENT PHARMS INC
217546 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2023/05/12 LAURUS
208928 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Discontinued No No AB 2023/11/20 IPCA LABS LTD
219319 001 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 100MG Prescription No No AB 2025/08/07 SENORES PHARMS
>>>活性成分:GABAPENTIN; 剂型/给药途径:CAPSULE;ORAL; 规格:300MG; 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
020235 002 NDA NEURONTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription Yes No AB 1993/12/30 VIATRIS
075350 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2003/09/12 ACTAVIS ELIZABETH
075477 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2005/03/23 CSPC OUYI
075360 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2005/04/06 GRANULES
077242 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Discontinued No No AB 2006/08/24 SUN PHARM INDS LTD
078428 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2007/07/25 AMNEAL PHARMS NY
078787 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2008/01/31 AUROBINDO PHARMA
090705 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2009/12/30 INVAGEN PHARMS
090858 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2010/12/17 ALKEM
090007 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2011/07/21 MARKSANS PHARMA
077261 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Discontinued No No AB 2013/08/02 TARO
204989 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2016/02/18 SCIEGEN PHARMS INC
207099 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2017/03/24 RISING
206943 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2018/05/14 STRIDES PHARMA
211314 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2018/10/16 STRIDES PHARMA
213603 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2020/08/17 ZHEJIANG YONGTAI
214956 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2021/05/10 ASCENT PHARMS INC
217546 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2023/05/12 LAURUS
208928 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Discontinued No No AB 2023/11/20 IPCA LABS LTD
219319 002 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 300MG Prescription No No AB 2025/08/07 SENORES PHARMS
>>>活性成分:GABAPENTIN; 剂型/给药途径:CAPSULE;ORAL; 规格:400MG; 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
020235 003 NDA NEURONTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription Yes Yes AB 1993/12/30 VIATRIS
075350 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2003/09/12 ACTAVIS ELIZABETH
075477 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2005/03/23 CSPC OUYI
075360 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2005/04/06 GRANULES
077242 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Discontinued No No AB 2006/08/24 SUN PHARM INDS LTD
078428 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2007/07/25 AMNEAL PHARMS NY
078787 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2008/01/31 AUROBINDO PHARMA
090705 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2009/12/30 INVAGEN PHARMS
090858 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2010/12/17 ALKEM
090007 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2011/07/21 MARKSANS PHARMA
077261 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Discontinued No No AB 2013/08/02 TARO
204989 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2016/02/18 SCIEGEN PHARMS INC
207099 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2017/03/24 RISING
206943 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2018/05/14 STRIDES PHARMA
211314 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2018/10/16 STRIDES PHARMA
213603 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2020/08/17 ZHEJIANG YONGTAI
214956 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2021/05/10 ASCENT PHARMS INC
217546 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2023/05/12 LAURUS
208928 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Discontinued No No AB 2023/11/20 IPCA LABS LTD
219319 003 ANDA GABAPENTIN GABAPENTIN CAPSULE;ORAL 400MG Prescription No No AB 2025/08/07 SENORES PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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