药品注册申请号：077627
申请类型：ANDA (仿制药申请)
申请人：GLENMARK PHARMS LTD
申请人全名：GLENMARK PHARMACEUTICALS 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 TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG No No AB 2009/03/27 2009/03/27 Prescription
002 TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG No No AB 2009/03/27 Prescription
003 TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG No No AB 2009/03/27 Prescription
004 TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG No No AB 2009/03/27 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
2024/02/22 SUPPL-24（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-23（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-21（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-20（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-19（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-18（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-17（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-16（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-14（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-9（补充） Approval Labeling STANDARD
2023/02/16 SUPPL-8（补充） Approval Labeling STANDARD
2014/12/01 SUPPL-7（补充） Approval Labeling STANDARD
2011/07/14 SUPPL-4（补充） Approval Labeling
2010/01/28 SUPPL-1（补充） Approval Labeling
2009/03/27 ORIG-1（原始申请） 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
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:TOPIRAMATE 剂型/给药途径:TABLET;ORAL 规格:25MG 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
020505 004 NDA TOPAMAX TOPIRAMATE TABLET;ORAL 25MG Prescription Yes No AB 1996/12/24 JANSSEN PHARMS
076311 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 ACCORD HLTHCARE
076327 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Discontinued No No AB 2009/03/27 SUN PHARM INDS LTD
076343 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 CIPLA LTD
077627 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 GLENMARK PHARMS LTD
077733 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 VIWIT PHARM
078235 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 ZYDUS PHARMS USA INC
078462 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 AUROBINDO PHARMA
079162 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 INVAGEN PHARMS
090162 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 UNICHEM LABS LTD
090278 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2009/03/27 SUN PHARM
215414 001 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 25MG Prescription No No AB 2021/08/26 ASCENT PHARMS INC
活性成分:TOPIRAMATE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
020505 005 NDA TOPAMAX TOPIRAMATE TABLET;ORAL 50MG Prescription Yes No AB 1996/12/24 JANSSEN PHARMS
076311 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 ACCORD HLTHCARE
076343 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 CIPLA LTD
077627 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 GLENMARK PHARMS LTD
077733 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 VIWIT PHARM
078235 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 ZYDUS PHARMS USA INC
078462 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 AUROBINDO PHARMA
079162 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 INVAGEN PHARMS
090162 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 UNICHEM LABS LTD
090278 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2009/03/27 SUN PHARM
215414 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 50MG Prescription No No AB 2021/08/26 ASCENT PHARMS INC
活性成分:TOPIRAMATE 剂型/给药途径:TABLET;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
020505 001 NDA TOPAMAX TOPIRAMATE TABLET;ORAL 100MG Prescription Yes Yes AB 1996/12/24 JANSSEN PHARMS
076311 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 ACCORD HLTHCARE
076327 002 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Discontinued No No AB 2009/03/27 SUN PHARM INDS LTD
076343 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 CIPLA LTD
077627 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 GLENMARK PHARMS LTD
077733 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 VIWIT PHARM
078235 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 ZYDUS PHARMS USA INC
078462 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 AUROBINDO PHARMA
079162 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 INVAGEN PHARMS
090162 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 UNICHEM LABS LTD
090278 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2009/03/27 SUN PHARM
215414 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 100MG Prescription No No AB 2021/08/26 ASCENT PHARMS INC
活性成分:TOPIRAMATE 剂型/给药途径:TABLET;ORAL 规格:200MG 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
020505 002 NDA TOPAMAX TOPIRAMATE TABLET;ORAL 200MG Prescription Yes No AB 1996/12/24 JANSSEN PHARMS
076311 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 ACCORD HLTHCARE
076327 003 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Discontinued No No AB 2009/03/27 SUN PHARM INDS LTD
076343 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 CIPLA LTD
077627 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 GLENMARK PHARMS LTD
077733 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 VIWIT PHARM
078235 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 ZYDUS PHARMS USA INC
078462 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 AUROBINDO PHARMA
079162 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 INVAGEN PHARMS
090278 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2009/03/27 SUN PHARM
090162 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2013/02/19 UNICHEM LABS LTD
215414 004 ANDA TOPIRAMATE TOPIRAMATE TABLET;ORAL 200MG Prescription No No AB 2021/08/26 ASCENT PHARMS INC
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database