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FILM, EXTENDED RELEASE;TRANSDERMAL 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 1990/08/07 Discontinued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FILM, EXTENDED RELEASE;TRANSDERMAL 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 Discontinued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FILM, EXTENDED RELEASE;TRANSDERMAL 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 Discontinued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FILM, EXTENDED RELEASE;TRANSDERMAL 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1990/08/07 Discontinued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FILM, EXTENDED RELEASE;TRANSDERMAL 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2005/02/04 Discontinued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FILM, EXTENDED RELEASE;TRANSDERMAL 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2018/01/24 Discontinued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
>>>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
1990/08/07 ORIG-1（原始申请） Approval Type 2 - New Active Ingredient and 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
2021/03/04 SUPPL-81（补充） Approval Labeling-Package Insert STANDARD
2019/10/07 SUPPL-79（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2018/09/18 SUPPL-76（补充） Approval Labeling-Package Insert STANDARD
2018/09/18 SUPPL-75（补充） Approval REMS - MODIFIED - D-N-A N/A
2018/01/24 SUPPL-73（补充） Approval STANDARD
2018/01/24 SUPPL-72（补充） Approval Efficacy-Manufacturing Change With Clinical Data STANDARD
2017/05/26 SUPPL-74（补充） Approval REMS-Modified N/A
2017/02/10 SUPPL-68（补充） Approval Labeling-Package Insert STANDARD
2017/02/02 SUPPL-70（补充） Approval Labeling-Container/Carton Labels STANDARD
2016/12/16 SUPPL-69（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2016/09/30 SUPPL-71（补充） Approval REMS - MODIFIED - D-N-A N/A
2016/04/20 SUPPL-67（补充） Approval REMS-Modified N/A
2015/06/26 SUPPL-66（补充） Approval REMS-Modified N/A
2014/08/19 SUPPL-65（补充） Approval REMS-Modified N/A
2014/06/08 SUPPL-64（补充） Approval Manufacturing (CMC) STANDARD
2014/04/16 SUPPL-63（补充） Approval Labeling-Package Insert 901 REQUIRED
2013/09/23 SUPPL-60（补充） Approval Labeling-Package Insert N/A
2013/07/26 SUPPL-59（补充） Approval Manufacturing (CMC) STANDARD
2013/04/15 SUPPL-56（补充） Approval REMS-Modified N/A
2012/12/19 SUPPL-55（补充） Approval Manufacturing (CMC) STANDARD
2012/07/09 SUPPL-52（补充） Approval REMS-Proposal N/A
2012/07/09 SUPPL-51（补充） Approval Labeling STANDARD
2009/07/31 SUPPL-44（补充） Approval Labeling-Container/Carton Labels,Labeling-Package Insert N/A
2008/02/07 SUPPL-33（补充） Approval Labeling STANDARD
2005/02/04 SUPPL-39（补充） Approval Efficacy-New Dosing Regimen UNKNOWN
2003/05/20 SUPPL-36（补充） Approval Efficacy-New Indication 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)-Control STANDARD
2000/11/09 SUPPL-28（补充） Approval Manufacturing (CMC)-Control 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)-Control STANDARD
1999/12/07 SUPPL-22（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1999/12/02 SUPPL-24（补充） Approval Manufacturing (CMC)-Control 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)-Control 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)-Formulation 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)-Control STANDARD
1990/10/22 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
1990/10/22 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
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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
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