药品注册申请号:020747
申请类型:NDA (新药申请)
申请人:CEPHALON
申请人全名:CEPHALON 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 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE;TRANSMUCOSAL EQ 0.2MG BASE Yes No None 1998/11/04 1998/11/04 Prescription
002 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE;TRANSMUCOSAL EQ 0.4MG BASE Yes Yes None 1998/11/04 Prescription
003 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE;TRANSMUCOSAL EQ 0.6MG BASE Yes No None 1998/11/04 Prescription
004 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE;TRANSMUCOSAL EQ 0.8MG BASE Yes No None 1998/11/04 Prescription
005 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE;TRANSMUCOSAL EQ 1.2MG BASE Yes No None 1998/11/04 Prescription
006 ACTIQ FENTANYL CITRATE TROCHE/LOZENGE;TRANSMUCOSAL EQ 1.6MG BASE Yes No None 1998/11/04 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
2023/12/15 SUPPL-62(补充) Approval Labeling STANDARD
2022/12/08 SUPPL-61(补充) Approval REMS N/A
2022/11/22 SUPPL-56(补充) Approval REMS N/A
2022/08/17 SUPPL-58(补充) Approval REMS N/A
2021/12/03 SUPPL-55(补充) Approval REMS N/A
2021/03/04 SUPPL-53(补充) Approval Labeling STANDARD
2020/12/23 SUPPL-50(补充) Approval REMS N/A
2019/10/07 SUPPL-49(补充) Approval Labeling STANDARD
2017/09/07 SUPPL-47(补充) Approval REMS N/A
2016/12/16 SUPPL-44(补充) Approval Labeling STANDARD
2016/12/16 SUPPL-43(补充) Approval Labeling STANDARD
2014/12/24 SUPPL-41(补充) Approval REMS N/A
2014/04/30 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
2013/11/07 SUPPL-37(补充) Approval REMS N/A
2013/04/22 SUPPL-39(补充) Approval Manufacturing (CMC) STANDARD
2012/06/05 SUPPL-34(补充) Approval REMS N/A
2011/12/28 SUPPL-33(补充) Approval REMS N/A
2011/07/20 SUPPL-29(补充) Approval Labeling STANDARD
2009/11/09 SUPPL-30(补充) Approval Labeling STANDARD
2007/02/07 SUPPL-27(补充) Approval Efficacy PRIORITY
2006/09/06 SUPPL-23(补充) Approval Labeling STANDARD
2005/09/09 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2005/01/19 SUPPL-18(补充) Approval Labeling STANDARD
2004/09/24 SUPPL-17(补充) Approval Labeling STANDARD
2003/02/19 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
2003/01/29 SUPPL-9(补充) Approval Labeling STANDARD
2002/06/10 SUPPL-11(补充) Approval Labeling STANDARD
2002/03/12 SUPPL-10(补充) Approval Labeling STANDARD
2001/04/09 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
2000/08/25 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1999/03/26 SUPPL-3(补充) Approval Labeling STANDARD
1999/03/26 SUPPL-2(补充) Approval Labeling STANDARD
1998/11/04 ORIG-1(原始申请) 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 4863737 2006/09/05 PDF格式**本条是由Drugfuture回溯的历史信息**
002 4863737 2006/09/05 PDF格式**本条是由Drugfuture回溯的历史信息**
003 4863737 2006/09/05 PDF格式**本条是由Drugfuture回溯的历史信息**
004 4863737 2006/09/05 PDF格式**本条是由Drugfuture回溯的历史信息**
005 4863737 2006/09/05 PDF格式**本条是由Drugfuture回溯的历史信息**
006 4863737 2006/09/05 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-63 2010/02/06**本条是由Drugfuture回溯的历史信息**
002 M-63 2010/02/06**本条是由Drugfuture回溯的历史信息**
003 M-63 2010/02/06**本条是由Drugfuture回溯的历史信息**
004 M-63 2010/02/06**本条是由Drugfuture回溯的历史信息**
005 M-63 2010/02/06**本条是由Drugfuture回溯的历史信息**
006 M-63 2010/02/06**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
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