药品注册申请号：019813
申请类型：NDA (新药申请)
申请人：JANSSEN PHARMS
申请人全名：JANSSEN PHARMACEUTICALS 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 DURAGESIC-100 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 1990/08/07 Discontinued
002 DURAGESIC-75 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 Discontinued
003 DURAGESIC-50 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 Discontinued
004 DURAGESIC-25 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 Discontinued
005 DURAGESIC-12 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2005/02/04 Discontinued
006 DURAGESIC-37 FENTANYL FILM, EXTENDED RELEASE;TRANSDERMAL 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2018/01/24 Discontinued
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
2021/03/04 SUPPL-81（补充） Approval Labeling STANDARD
2019/10/07 SUPPL-79（补充） Approval Labeling STANDARD
2018/09/18 SUPPL-76（补充） Approval Labeling STANDARD
2018/09/18 SUPPL-75（补充） Approval REMS N/A
2018/01/24 SUPPL-73（补充） Approval Manufacturing (CMC) STANDARD
2018/01/24 SUPPL-72（补充） Approval Efficacy STANDARD
2017/05/26 SUPPL-74（补充） Approval REMS N/A
2017/02/10 SUPPL-68（补充） Approval Labeling STANDARD
2017/02/02 SUPPL-70（补充） Approval Labeling STANDARD
2016/12/16 SUPPL-69（补充） Approval Labeling STANDARD
2016/09/30 SUPPL-71（补充） Approval REMS N/A
2016/04/20 SUPPL-67（补充） Approval REMS N/A
2015/06/26 SUPPL-66（补充） Approval REMS N/A
2014/08/19 SUPPL-65（补充） Approval REMS N/A
2014/06/08 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
2014/04/16 SUPPL-63（补充） Approval Labeling 901 REQUIRED
2013/09/23 SUPPL-60（补充） Approval Manufacturing (CMC) N/A
2013/07/26 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
2013/04/15 SUPPL-56（补充） Approval REMS N/A
2012/12/19 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
2012/07/09 SUPPL-52（补充） Approval REMS N/A
2012/07/09 SUPPL-51（补充） Approval Labeling STANDARD
2009/07/31 SUPPL-44（补充） Approval Manufacturing (CMC) N/A
2008/02/07 SUPPL-33（补充） Approval Labeling STANDARD
2005/02/04 SUPPL-39（补充） Approval Efficacy UNKNOWN
2003/05/20 SUPPL-36（补充） Approval Efficacy PRIORITY
2001/04/11 SUPPL-23（补充） Approval Labeling STANDARD
2001/04/09 SUPPL-30（补充） Approval Labeling STANDARD
2000/11/09 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
2000/11/09 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2000/11/01 SUPPL-26（补充） Approval Labeling STANDARD
2000/11/01 SUPPL-25（补充） Approval Labeling STANDARD
2000/04/26 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
1999/12/07 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1999/12/02 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1997/07/17 SUPPL-21（补充） Approval Labeling STANDARD
1997/07/17 SUPPL-20（补充） Approval Labeling STANDARD
1997/07/17 SUPPL-19（补充） Approval Labeling STANDARD
1997/07/17 SUPPL-18（补充） Approval Labeling STANDARD
1997/06/19 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
1994/11/07 SUPPL-17（补充） Approval Labeling STANDARD
1994/03/29 SUPPL-16（补充） Approval Labeling STANDARD
1994/01/11 SUPPL-14（补充） Approval Labeling STANDARD
1993/10/25 SUPPL-12（补充） Approval Labeling STANDARD
1993/07/28 SUPPL-10（补充） Approval Labeling STANDARD
1993/06/11 SUPPL-11（补充） Approval Manufacturing (CMC) STANDARD
1991/07/05 SUPPL-8（补充） Approval Manufacturing (CMC) STANDARD
1991/06/12 SUPPL-9（补充） Approval Manufacturing (CMC) STANDARD
1991/02/12 SUPPL-7（补充） Approval Manufacturing (CMC) STANDARD
1990/10/22 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1990/10/22 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
1990/08/07 ORIG-1（原始申请） Approval Type 2 - New Active Ingredient and 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
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
001 PED 2006/11/20**本条是由Drugfuture回溯的历史信息**
002 PED 2006/11/20**本条是由Drugfuture回溯的历史信息**
003 PED 2006/11/20**本条是由Drugfuture回溯的历史信息**
004 PED 2006/11/20**本条是由Drugfuture回溯的历史信息**
005 PED 2006/11/20**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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