药品注册申请号：077154
申请类型：ANDA (仿制药申请)
申请人：SPECGX LLC
申请人全名：SPECGX 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 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR No Yes AB 2011/02/09 2011/02/09 Prescription
002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR No No AB 2011/02/09 Prescription
003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR No No AB 2011/02/09 Prescription
004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR No No AB 2011/02/09 Prescription
005 FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR No No AB 2015/06/11 Prescription
006 FENTANYL-37 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 37.5MCG/HR No No AB 2020/01/14 Prescription
007 FENTANYL-62 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 62.5MCG/HR No No AB 2020/01/14 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
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
2024/10/31 SUPPL-39（补充） Approval REMS
2023/12/15 SUPPL-37（补充） Approval Labeling STANDARD
2023/12/15 SUPPL-35（补充） Approval Labeling STANDARD
2023/12/08 SUPPL-29（补充） Approval Labeling STANDARD
2020/05/06 SUPPL-25（补充） Approval Labeling STANDARD
2020/05/06 SUPPL-24（补充） Approval Labeling STANDARD
2020/05/06 SUPPL-23（补充） Approval Labeling STANDARD
2020/05/06 SUPPL-21（补充） Approval Labeling STANDARD
2020/05/06 SUPPL-19（补充） Approval Labeling STANDARD
2018/09/18 SUPPL-20（补充） Approval REMS
2017/05/26 SUPPL-17（补充） Approval REMS
2016/09/30 SUPPL-16（补充） Approval REMS
2016/04/20 SUPPL-12（补充） Approval REMS
2015/06/26 SUPPL-11（补充） Approval REMS
2015/06/11 SUPPL-2（补充） Approval Manufacturing (CMC)
2014/08/19 SUPPL-10（补充） Approval REMS
2014/06/16 SUPPL-8（补充） Approval Labeling STANDARD
2013/04/15 SUPPL-6（补充） Approval REMS
2012/07/09 SUPPL-5（补充） Approval Labeling
2012/07/09 SUPPL-3（补充） Approval REMS
2011/02/09 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:FENTANYL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:25MCG/HR 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
076258 001 ANDA FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR Prescription No No AB 2005/01/28 MYLAN TECHNOLOGIES
077449 001 ANDA FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR Prescription No No AB 2008/10/20 DIFGEN PHARMS
077154 001 ANDA FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR Prescription No Yes AB 2011/02/09 SPECGX LLC
202097 002 ANDA FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR Prescription No No AB 2016/11/04 KINDEVA
209655 002 ANDA FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR Discontinued No No AB 2023/01/24 ZYDUS PHARMS
活性成分:FENTANYL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:50MCG/HR 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
076258 002 ANDA FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR Prescription No No AB 2005/01/28 MYLAN TECHNOLOGIES
077449 002 ANDA FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR Prescription No No AB 2008/10/20 DIFGEN PHARMS
077154 002 ANDA FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR Prescription No No AB 2011/02/09 SPECGX LLC
202097 003 ANDA FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR Prescription No No AB 2016/11/04 KINDEVA
209655 004 ANDA FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR Discontinued No No AB 2023/01/24 ZYDUS PHARMS
活性成分:FENTANYL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:75MCG/HR 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
076258 003 ANDA FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR Prescription No No AB 2005/01/28 MYLAN TECHNOLOGIES
077449 003 ANDA FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR Prescription No No AB 2008/10/20 DIFGEN PHARMS
077154 003 ANDA FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR Prescription No No AB 2011/02/09 SPECGX LLC
202097 004 ANDA FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR Prescription No No AB 2016/11/04 KINDEVA
209655 006 ANDA FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR Discontinued No No AB 2023/01/24 ZYDUS PHARMS
活性成分:FENTANYL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:100MCG/HR 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
076258 004 ANDA FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR Prescription No No AB 2005/01/28 MYLAN TECHNOLOGIES
077449 004 ANDA FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR Prescription No No AB 2008/10/20 DIFGEN PHARMS
077154 004 ANDA FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR Prescription No No AB 2011/02/09 SPECGX LLC
202097 005 ANDA FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR Prescription No No AB 2016/11/04 KINDEVA
209655 008 ANDA FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR Discontinued No No AB 2023/01/24 ZYDUS PHARMS
活性成分:FENTANYL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:12.5MCG/HR 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
076258 005 ANDA FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR Prescription No No AB 2007/01/23 MYLAN TECHNOLOGIES
077154 005 ANDA FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR Prescription No No AB 2015/06/11 SPECGX LLC
077449 005 ANDA FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR Prescription No No AB 2015/09/11 DIFGEN PHARMS
202097 001 ANDA FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR Prescription No No AB 2016/11/04 KINDEVA
209655 001 ANDA FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR Discontinued No No AB 2023/01/24 ZYDUS PHARMS
活性成分:FENTANYL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:37.5MCG/HR 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
076258 006 ANDA FENTANYL-37 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 37.5MCG/HR Prescription No No AB 2014/12/29 MYLAN TECHNOLOGIES
077449 006 ANDA FENTANYL-37 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 37.5MCG/HR Prescription No No AB 2017/12/06 DIFGEN PHARMS
077154 006 ANDA FENTANYL-37 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 37.5MCG/HR Prescription No No AB 2020/01/14 SPECGX LLC
209655 003 ANDA FENTANYL-37 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 37.5MCG/HR Discontinued No No AB 2023/01/24 ZYDUS PHARMS
活性成分:FENTANYL 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:62.5MCG/HR 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
076258 007 ANDA FENTANYL-62 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 62.5MCG/HR Prescription No No AB 2014/12/29 MYLAN TECHNOLOGIES
077449 007 ANDA FENTANYL-62 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 62.5MCG/HR Prescription No No AB 2017/12/06 DIFGEN PHARMS
077154 007 ANDA FENTANYL-62 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 62.5MCG/HR Prescription No No AB 2020/01/14 SPECGX LLC
209655 005 ANDA FENTANYL-62 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 62.5MCG/HR Discontinued No No AB 2023/01/24 ZYDUS PHARMS
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