药品注册申请号:020657
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 SPORANOX ITRACONAZOLE SOLUTION;ORAL 10MG/ML Yes Yes AA 1997/02/21 1997/02/21 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
2024/03/18 SUPPL-42(补充) Approval Labeling STANDARD
2024/02/05 SUPPL-40(补充) Approval Labeling STANDARD
2023/10/19 SUPPL-39(补充) Approval Labeling STANDARD
2022/12/05 SUPPL-38(补充) Approval Labeling STANDARD
2019/03/08 SUPPL-37(补充) Approval Labeling STANDARD
2017/10/07 SUPPL-36(补充) Approval Labeling STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
2017/03/17 SUPPL-35(补充) Approval Labeling STANDARD
2015/04/16 SUPPL-33(补充) Approval Labeling STANDARD
2014/06/09 SUPPL-32(补充) Approval Labeling STANDARD
2013/06/06 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
2012/03/26 SUPPL-28(补充) Approval Labeling STANDARD
2012/03/26 SUPPL-27(补充) Approval Labeling UNKNOWN
2011/04/15 SUPPL-26(补充) Approval Labeling UNKNOWN
2011/01/04 SUPPL-25(补充) Approval Labeling UNKNOWN
2010/07/29 SUPPL-24(补充) Approval Labeling UNKNOWN
2009/03/05 SUPPL-21(补充) Approval Labeling STANDARD
2009/03/05 SUPPL-19(补充) Approval Labeling STANDARD
2009/03/05 SUPPL-18(补充) Approval Labeling STANDARD
2009/03/05 SUPPL-11(补充) Approval Labeling STANDARD
2003/09/24 SUPPL-10(补充) Approval Labeling STANDARD
2002/10/10 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
2002/09/11 SUPPL-7(补充) Approval Labeling STANDARD
2002/07/17 SUPPL-8(补充) Approval Labeling STANDARD
2001/05/09 SUPPL-5(补充) Approval Efficacy STANDARD
2001/05/09 SUPPL-4(补充) Approval Labeling STANDARD
2001/04/25 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1998/07/27 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1998/07/27 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1998/02/20 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1997/02/21 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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 5707975 2015/01/13 PDF格式**本条是由Drugfuture回溯的历史信息**
6407079 2019/06/18 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
与本品治疗等效的药品
活性成分:ITRACONAZOLE 剂型/给药途径:SOLUTION;ORAL 规格:10MG/ML 治疗等效代码:AA
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
020657 001 NDA SPORANOX ITRACONAZOLE SOLUTION;ORAL 10MG/ML Prescription Yes Yes AA 1997/02/21 JANSSEN PHARMS
205573 001 ANDA ITRACONAZOLE ITRACONAZOLE SOLUTION;ORAL 10MG/ML Prescription No No AA 2015/10/30 AMNEAL PHARMS
212239 001 ANDA ITRACONAZOLE ITRACONAZOLE SOLUTION;ORAL 10MG/ML Prescription No No AA 2020/09/01 ANNORA PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
©2006-2024 DrugFuture->U.S. FDA Drugs Database