药品注册申请号:208269
申请类型:ANDA (仿制药申请)
申请人:ALVOGEN
申请人全名:ALVOGEN 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 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 20MG No No AB 2021/03/01 2021/03/01 Prescription
002 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 30MG No No AB 2021/03/01 Prescription
003 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 40MG No No AB 2021/03/01 Prescription
004 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 60MG No No AB 2021/03/01 Prescription
005 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 80MG No No AB 2021/03/01 Prescription
006 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 100MG No No AB 2021/03/01 Prescription
007 HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 120MG No No AB 2021/03/01 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
2021/03/01 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:HYDROCODONE BITARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:20MG 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
206627 001 NDA HYSINGLA ER HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 20MG Prescription Yes Yes AB 2014/11/20 PURDUE PHARMA LP
208269 001 ANDA HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 20MG Prescription No No AB 2021/03/01 ALVOGEN
活性成分:HYDROCODONE BITARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:30MG 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
206627 002 NDA HYSINGLA ER HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription Yes No AB 2014/11/20 PURDUE PHARMA LP
208269 002 ANDA HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2021/03/01 ALVOGEN
活性成分:HYDROCODONE BITARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:40MG 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
206627 003 NDA HYSINGLA ER HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 40MG Prescription Yes No AB 2014/11/20 PURDUE PHARMA LP
208269 003 ANDA HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 40MG Prescription No No AB 2021/03/01 ALVOGEN
活性成分:HYDROCODONE BITARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:60MG 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
206627 004 NDA HYSINGLA ER HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription Yes No AB 2014/11/20 PURDUE PHARMA LP
208269 004 ANDA HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2021/03/01 ALVOGEN
活性成分:HYDROCODONE BITARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:80MG 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
206627 005 NDA HYSINGLA ER HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 80MG Prescription Yes No AB 2014/11/20 PURDUE PHARMA LP
208269 005 ANDA HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 80MG Prescription No No AB 2021/03/01 ALVOGEN
活性成分:HYDROCODONE BITARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;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
206627 006 NDA HYSINGLA ER HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription Yes No AB 2014/11/20 PURDUE PHARMA LP
208269 006 ANDA HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 100MG Prescription No No AB 2021/03/01 ALVOGEN
活性成分:HYDROCODONE BITARTRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:120MG 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
206627 007 NDA HYSINGLA ER HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription Yes No AB 2014/11/20 PURDUE PHARMA LP
208269 007 ANDA HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2021/03/01 ALVOGEN
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2023 DrugFuture->U.S. FDA Drugs Database