药品注册申请号:021821
申请类型:NDA (新药申请)
申请人:PF PRISM CV
申请人全名:PF PRISM CV
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 TYGACIL TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Yes Yes AP 2005/06/15 2005/06/15 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
2020/06/23 SUPPL-49(补充) Approval Labeling STANDARD
2020/01/16 SUPPL-48(补充) Approval Labeling STANDARD
2018/04/16 SUPPL-45(补充) Approval Labeling STANDARD
2016/06/29 SUPPL-42(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.
2016/05/31 SUPPL-39(补充) Approval Labeling STANDARD
2016/01/19 SUPPL-43(补充) Approval Labeling STANDARD
2014/01/09 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
2013/09/26 SUPPL-31(补充) Approval Labeling STANDARD
2013/09/26 SUPPL-26(补充) Approval Labeling UNKNOWN
2013/05/23 SUPPL-37(补充) Approval Labeling STANDARD
2010/07/16 SUPPL-27(补充) Approval Labeling UNKNOWN
2010/07/16 SUPPL-25(补充) Approval Labeling UNKNOWN
2010/07/16 SUPPL-21(补充) Approval Labeling STANDARD
2009/06/26 SUPPL-22(补充) Approval Manufacturing (CMC) N/A
2009/03/20 SUPPL-18(补充) Approval Efficacy UNKNOWN
2009/03/20 SUPPL-17(补充) Approval Efficacy UNKNOWN
2009/03/20 SUPPL-13(补充) Approval Efficacy UNKNOWN
2009/02/10 SUPPL-16(补充) Approval Labeling STANDARD
2009/01/29 SUPPL-19(补充) Approval Labeling STANDARD
2009/01/29 SUPPL-14(补充) Approval Labeling STANDARD
2009/01/29 SUPPL-11(补充) Approval Labeling STANDARD
2007/05/18 SUPPL-10(补充) Approval Labeling STANDARD
2007/04/03 SUPPL-7(补充) Approval Labeling STANDARD
2007/01/24 SUPPL-6(补充) Approval Labeling STANDARD
2006/07/12 SUPPL-4(补充) Approval Manufacturing (CMC) N/A
2006/07/12 SUPPL-3(补充) Approval Labeling STANDARD
2005/06/15 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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 10588975 2026/03/13 Y 2020/04/15 PDF格式
7879828 2029/02/05 Y PDF格式
8372995 2030/10/08 Y 2013/02/28 PDF格式
8975242 2028/10/24 Y 2015/03/10 PDF格式
9254328 2026/03/13 Y 2016/03/04 PDF格式
9694078 2026/03/13 Y 2017/08/01 PDF格式
001 5494903 2012/08/13 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
5529990 2013/06/25 U-282 PDF格式**本条是由Drugfuture回溯的历史信息**
RE40086 2013/06/25 U-282 PDF格式**本条是由Drugfuture回溯的历史信息**
RE40183 2016/04/09 Y Y 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 NCE 2010/06/15**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:TIGECYCLINE 剂型/给药途径:POWDER;INTRAVENOUS 规格:50MG/VIAL 治疗等效代码:AP
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
021821 001 NDA TYGACIL TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Prescription Yes Yes AP 2005/06/15 PF PRISM CV
091620 001 ANDA TIGECYCLINE TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Prescription No No AP 2015/05/27 SANDOZ
205645 001 NDA TIGECYCLINE TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Prescription Yes Yes AP 2016/12/01 FRESENIUS KABI USA
211158 001 NDA TIGECYCLINE TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Prescription No No AP 2018/08/02 AMNEAL
204439 001 ANDA TIGECYCLINE TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Prescription No No AP 2018/12/21 APOTEX
206335 001 ANDA TIGECYCLINE TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Prescription No No AP 2019/06/11 EUGIA PHARMA
205722 001 ANDA TIGECYCLINE TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Discontinued No No AP 2019/10/18 XELLIA PHARMS APS
214020 001 ANDA TIGECYCLINE TIGECYCLINE POWDER;INTRAVENOUS 50MG/VIAL Prescription No No AP 2021/05/13 MEITHEAL
更多信息
药品NDC数据与药品包装、标签说明书
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