药品注册申请号:021306
申请类型:NDA (新药申请)
申请人:PURDUE PHARMA LP
申请人全名:PURDUE PHARMA LP
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 BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 5MCG/HR Yes No AB 2010/06/30 2010/06/30 Prescription
002 BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 10MCG/HR Yes No AB 2010/06/30 Prescription
003 BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 20MCG/HR Yes Yes AB 2010/06/30 Prescription
004 BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 15MCG/HR Yes No AB 2013/07/25 Prescription
005 BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 7.5MCG/HR Yes No AB 2014/06/30 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2019/10/07 SUPPL 35 Approval Labeling STANDARD
2018/09/18 SUPPL 34 Approval Labeling STANDARD
2018/09/18 SUPPL 32 Approval REMS N/A
2017/10/13 SUPPL 27 Approval Efficacy STANDARD
2017/08/14 SUPPL 31 Approval REMS N/A
2017/05/26 SUPPL 30 Approval REMS N/A
2016/12/16 SUPPL 24 Approval Labeling STANDARD
2016/09/30 SUPPL 26 Approval REMS N/A
2016/04/20 SUPPL 23 Approval REMS N/A
2015/06/26 SUPPL 22 Approval REMS N/A
2014/08/19 SUPPL 20 Approval REMS N/A
2014/06/30 SUPPL 19 Approval Manufacturing (CMC) STANDARD
2014/06/30 SUPPL 15 Approval Labeling STANDARD
2014/04/16 SUPPL 18 Approval Labeling 901 REQUIRED
2013/07/25 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2013/04/15 SUPPL 12 Approval REMS N/A
2013/03/08 SUPPL 13 Approval Manufacturing (CMC) STANDARD
2012/07/09 SUPPL 8 Approval Labeling STANDARD
2011/07/01 SUPPL 3 Approval Labeling STANDARD
2011/07/01 SUPPL 1 Approval Labeling STANDARD
2010/06/30 ORIG 1 Approval Type 3 - New Dosage Form 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
001 6264980 2015/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6344211 2015/12/18 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6264980 2015/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6344211 2015/12/18 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6264980 2015/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6344211 2015/12/18 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
004 6264980 2015/12/18 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6344211 2015/12/18 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 M-250 2020/10/13
002 M-250 2020/10/13
003 M-250 2020/10/13
004 M-250 2020/10/13
005 M-250 2020/10/13
与本品治疗等效的药品
活性成分:BUPRENORPHINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格: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
021306 001 NDA BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 5MCG/HR Prescription Yes No AB 2010/06/30 PURDUE PHARMA LP
204937 001 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 5MCG/HR Prescription No No AB 2018/11/20 WATSON LABS TEVA
211586 001 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 5MCG/HR Prescription No No AB 2020/04/14 AMNEAL PHARMS LLC
活性成分:BUPRENORPHINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:10MCG/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
021306 002 NDA BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 10MCG/HR Prescription Yes No AB 2010/06/30 PURDUE PHARMA LP
204937 002 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 10MCG/HR Prescription No No AB 2018/11/20 WATSON LABS TEVA
211586 003 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 10MCG/HR Prescription No No AB 2020/04/14 AMNEAL PHARMS LLC
活性成分:BUPRENORPHINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:20MCG/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
021306 003 NDA BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 20MCG/HR Prescription Yes Yes AB 2010/06/30 PURDUE PHARMA LP
204937 004 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 20MCG/HR Prescription No No AB 2018/11/20 WATSON LABS TEVA
211586 005 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 20MCG/HR Prescription No No AB 2020/04/14 AMNEAL PHARMS LLC
活性成分:BUPRENORPHINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:15MCG/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
021306 004 NDA BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 15MCG/HR Prescription Yes No AB 2013/07/25 PURDUE PHARMA LP
204937 003 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 15MCG/HR Prescription No No AB 2018/11/20 WATSON LABS TEVA
211586 004 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 15MCG/HR Prescription No No AB 2020/04/14 AMNEAL PHARMS LLC
活性成分:BUPRENORPHINE 剂型/给药途径:FILM, EXTENDED RELEASE;TRANSDERMAL 规格:7.5MCG/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
021306 005 NDA BUTRANS BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 7.5MCG/HR Prescription Yes No AB 2014/06/30 PURDUE PHARMA LP
211586 002 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 7.5MCG/HR Prescription No No AB 2020/04/14 AMNEAL PHARMS LLC
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