药品注册申请号:020990
申请类型:NDA (新药申请)
申请人:VIATRIS
申请人全名:VIATRIS SPECIALTY 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 ZOLOFT SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML Yes Yes AA 1999/12/07 1999/12/07 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
2023/08/18 SUPPL-62(补充) Approval Labeling STANDARD
2023/01/25 SUPPL-59(补充) Approval Labeling STANDARD
2021/09/20 SUPPL-57(补充) Approval Labeling 901 REQUIRED
2017/12/08 SUPPL-50(补充) Approval Labeling STANDARD
2017/12/08 SUPPL-49(补充) Approval Labeling STANDARD
2017/06/15 SUPPL-46(补充) Approval Labeling STANDARD
2016/12/23 SUPPL-45(补充) Approval Labeling 901 REQUIRED
2016/12/23 SUPPL-44(补充) Approval Labeling STANDARD
2016/12/23 SUPPL-35(补充) Approval Labeling STANDARD
2014/09/12 SUPPL-43(补充) Approval Labeling STANDARD
2014/07/03 SUPPL-41(补充) Approval Labeling STANDARD
2014/07/03 SUPPL-39(补充) Approval Labeling 901 REQUIRED
2013/10/15 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
2013/02/01 SUPPL-38(补充) Approval Labeling STANDARD
2012/12/18 SUPPL-40(补充) Approval Labeling STANDARD
2012/12/18 SUPPL-34(补充) Approval Labeling STANDARD
2011/08/19 SUPPL-37(补充) Approval Labeling STANDARD
2011/08/19 SUPPL-36(补充) Approval Labeling STANDARD
2011/08/19 SUPPL-33(补充) Approval Labeling STANDARD
2009/01/30 SUPPL-32(补充) Approval Labeling 901 REQUIRED
2008/03/06 SUPPL-31(补充) Approval Labeling STANDARD
2007/10/04 SUPPL-29(补充) Approval Labeling STANDARD
2007/08/02 SUPPL-27(补充) Approval Labeling STANDARD
2007/08/02 SUPPL-25(补充) Approval Labeling STANDARD
2006/09/14 SUPPL-26(补充) Approval Labeling STANDARD
2006/09/14 SUPPL-24(补充) Approval Labeling STANDARD
2006/05/04 SUPPL-23(补充) Approval Labeling STANDARD
2005/07/26 SUPPL-22(补充) Approval Labeling STANDARD
2005/02/18 SUPPL-20(补充) Approval Labeling STANDARD
2005/02/18 SUPPL-19(补充) Approval Labeling STANDARD
2004/08/19 SUPPL-17(补充) Approval Labeling STANDARD
2004/08/19 SUPPL-13(补充) Approval Efficacy STANDARD
2003/09/16 SUPPL-10(补充) Approval Efficacy STANDARD
2003/02/07 SUPPL-11(补充) Approval Efficacy STANDARD
2002/09/20 SUPPL-4(补充) Approval Efficacy STANDARD
2002/09/20 SUPPL-2(补充) Approval Efficacy STANDARD
2002/09/18 SUPPL-9(补充) Approval Labeling STANDARD
2002/05/16 SUPPL-7(补充) Approval Efficacy STANDARD
2001/10/12 SUPPL-1(补充) Approval Efficacy STANDARD
2001/08/06 SUPPL-3(补充) Approval Efficacy STANDARD
2001/02/22 SUPPL-5(补充) Approval Labeling STANDARD
2000/11/16 SUPPL-6(补充) Approval Labeling STANDARD
1999/12/07 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 5248699 2012/08/13 PDF格式**本条是由Drugfuture回溯的历史信息**
5248699*PED 2013/02/13 PDF格式**本条是由Drugfuture回溯的历史信息**
5744501 2009/01/06 U-461 PDF格式**本条是由Drugfuture回溯的历史信息**
5789449 2009/01/06 U-460 PDF格式**本条是由Drugfuture回溯的历史信息**
6727283 2019/10/11 Y U-580 PDF格式**本条是由Drugfuture回溯的历史信息**
6727283*PED 2020/04/11 PDF格式**本条是由Drugfuture回溯的历史信息**
7067555 2019/10/11 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7067555 2019/11/10 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7067555*PED 2020/04/11 PDF格式**本条是由Drugfuture回溯的历史信息**
7067555*PED 2020/05/10 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:SERTRALINE HYDROCHLORIDE 剂型/给药途径:CONCENTRATE;ORAL 规格:EQ 20MG BASE/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
020990 001 NDA ZOLOFT SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML Prescription Yes Yes AA 1999/12/07 VIATRIS
076934 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML Prescription No No AA 2006/06/30 ACI
078861 001 ANDA SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE CONCENTRATE;ORAL EQ 20MG BASE/ML Prescription No No AA 2008/10/31 AUROBINDO PHARMA
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