药品注册申请号：078503
申请类型：ANDA (仿制药申请)
申请人：OSMOTICA PHARM US
申请人全名：OSMOTICA PHARMACEUTICAL US LLC
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 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG No No AB 2009/02/04 2009/02/04 Prescription
002 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG No No AB 2009/02/04 Prescription
003 OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG No No AB 2009/02/04 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
2019/09/09 SUPPL-9（补充） Approval Labeling STANDARD
2019/09/09 SUPPL-7（补充） Approval Labeling STANDARD
2015/11/04 SUPPL-6（补充） Approval Labeling STANDARD
2015/11/04 SUPPL-5（补充） Approval Labeling STANDARD
2013/08/30 SUPPL-4（补充） Approval Labeling STANDARD
2013/08/30 SUPPL-3（补充） Approval Labeling STANDARD
2010/04/07 SUPPL-2（补充） Approval Labeling
2009/02/04 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:OXYBUTYNIN CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;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
020897 001 NDA DITROPAN XL OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Discontinued Yes No AB 1998/12/16 JANSSEN PHARMS
078503 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2009/02/04 OSMOTICA PHARM US
204010 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2015/11/23 AMNEAL PHARMS
207138 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2016/02/29 ACCORD HLTHCARE
206121 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2016/05/27 UNIQUE
202332 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2017/06/26 ZYDUS PHARMS
211655 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2019/02/28 AJANTA PHARMA LTD
210717 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2019/12/17 BIONPHARMA
214415 001 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG Prescription No No AB 2020/10/27 RUBICON
活性成分:OXYBUTYNIN CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;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
020897 002 NDA DITROPAN XL OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Discontinued Yes No AB 1998/12/16 JANSSEN PHARMS
078503 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2009/02/04 OSMOTICA PHARM US
204010 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2015/11/23 AMNEAL PHARMS
207138 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2016/02/29 ACCORD HLTHCARE
206121 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2016/05/27 UNIQUE
202332 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2017/06/26 ZYDUS PHARMS
211655 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2019/02/28 AJANTA PHARMA LTD
210717 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2019/12/17 BIONPHARMA
214415 002 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG Prescription No No AB 2020/10/27 RUBICON
活性成分:OXYBUTYNIN CHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;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
078503 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2009/02/04 OSMOTICA PHARM US
204010 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2015/11/23 AMNEAL PHARMS
207138 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No Yes AB 2016/02/29 ACCORD HLTHCARE
206121 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2016/05/27 UNIQUE
202332 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2017/06/26 ZYDUS PHARMS
211655 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2019/02/28 AJANTA PHARMA LTD
210717 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2019/12/17 BIONPHARMA
214415 003 ANDA OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG Prescription No No AB 2020/10/27 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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