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
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2010/06/30 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；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-42（补充） Approval REMS - MODIFIED - D-N-A N/A
2023/12/15 SUPPL-41（补充） Approval Labeling-Package Insert STANDARD
2022/06/17 SUPPL-39（补充） Approval Labeling-Package Insert STANDARD
2021/03/04 SUPPL-37（补充） Approval Labeling-Package Insert STANDARD
2019/10/07 SUPPL-35（补充） Approval Labeling-Package Insert STANDARD
2018/09/18 SUPPL-34（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2018/09/18 SUPPL-32（补充） Approval REMS - MODIFIED - D-N-A N/A
2017/10/13 SUPPL-27（补充） Approval Efficacy-New Patient Population STANDARD
2017/08/14 SUPPL-31（补充） Approval REMS - MODIFIED - D-N-A N/A
2017/05/26 SUPPL-30（补充） Approval REMS-Modified N/A
2016/12/16 SUPPL-24（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2016/09/30 SUPPL-26（补充） Approval REMS - MODIFIED - D-N-A N/A
2016/04/20 SUPPL-23（补充） Approval REMS-Modified N/A
2015/06/26 SUPPL-22（补充） Approval REMS-Modified N/A
2014/08/19 SUPPL-20（补充） Approval REMS-Modified N/A
2014/06/30 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2014/06/30 SUPPL-15（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels STANDARD
2014/04/16 SUPPL-18（补充） Approval Labeling-Package Insert 901 REQUIRED
2013/07/25 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
2013/04/15 SUPPL-12（补充） Approval REMS-Modified N/A
2013/03/08 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2012/07/09 SUPPL-8（补充） Approval Labeling,REMS-Modified STANDARD
2011/07/01 SUPPL-3（补充） Approval Labeling STANDARD
2011/07/01 SUPPL-1（补充） Approval Labeling-Patient Package Insert 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**
9642850 2017/09/29 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1072 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 U-1556 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**
9642850 2017/09/29 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1556 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 U-1556 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**
9642850 2017/09/29 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1556 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 U-1556 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**
9642850 2017/09/29 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1072 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1072 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1072 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
005 9642850 2017/09/29 U-1556 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41408 2017/09/29 U-1556 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41489 2017/09/29 U-1556 U-1072 PDF格式**本条是由Drugfuture回溯的历史信息**
RE41571 2017/09/29 U-1556 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**本条是由Drugfuture回溯的历史信息**
002 M-250 2020/10/13**本条是由Drugfuture回溯的历史信息**
003 M-250 2020/10/13**本条是由Drugfuture回溯的历史信息**
004 M-250 2020/10/13**本条是由Drugfuture回溯的历史信息**
005 M-250 2020/10/13**本条是由Drugfuture回溯的历史信息**
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
210272 001 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 5MCG/HR Prescription No No AB 2021/09/23 DIFGEN PHARMS
207490 001 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 5MCG/HR Prescription No No AB 2022/05/17 STRIDES PHARMA INTL
>>>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
210272 003 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 10MCG/HR Prescription No No AB 2021/09/23 DIFGEN PHARMS
207490 002 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 10MCG/HR Prescription No No AB 2022/05/17 STRIDES PHARMA INTL
>>>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
210272 005 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 20MCG/HR Prescription No No AB 2021/09/23 DIFGEN PHARMS
207490 004 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 20MCG/HR Prescription No No AB 2022/05/17 STRIDES PHARMA INTL
>>>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
210272 004 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 15MCG/HR Prescription No No AB 2021/09/23 DIFGEN PHARMS
207490 003 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 15MCG/HR Prescription No No AB 2022/05/17 STRIDES PHARMA INTL
>>>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
204937 005 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 7.5MCG/HR Prescription No No AB 2021/06/29 WATSON LABS TEVA
210272 002 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 7.5MCG/HR Prescription No No AB 2021/09/23 DIFGEN PHARMS
207490 005 ANDA BUPRENORPHINE BUPRENORPHINE FILM, EXTENDED RELEASE;TRANSDERMAL 7.5MCG/HR Discontinued No No AB 2023/03/21 STRIDES PHARMA INTL
更多信息
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