药品注册申请号:208840
申请类型:ANDA (仿制药申请)
申请人:AMNEAL PHARMS CO
申请人全名:AMNEAL PHARMACEUTICALS CO GMBH
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 TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML No No AP 2017/02/28 2017/02/28 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
2021/06/24 SUPPL-4(补充) Approval Labeling STANDARD
2021/06/24 SUPPL-2(补充) Approval Labeling STANDARD
2018/05/14 SUPPL-1(补充) Approval Labeling STANDARD
2017/02/28 ORIG-1(原始申请) Approval 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
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:TRANEXAMIC ACID 剂型/给药途径:INJECTABLE;INJECTION 规格:100MG/ML 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
019281 001 NDA CYKLOKAPRON TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription Yes Yes AP 1986/12/30 PFIZER
201885 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2011/08/10 AM REGENT
091657 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2011/11/03 MYLAN INSTITUTIONAL
202373 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2011/11/17 EPIC PHARMA LLC
091596 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2012/03/02 FRESENIUS KABI USA
201580 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2013/06/14 XGEN PHARMS
202436 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2014/02/11 ACIC PHARMS
203521 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2014/08/12 AVET LIFESCIENCES
205035 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2016/01/14 EUGIA PHARMA
206634 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Discontinued No No AP 2016/06/09 RISING
207239 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2017/02/13 GLAND
208840 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2017/02/28 AMNEAL PHARMS CO
206713 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2017/06/27 MICRO LABS
206594 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Discontinued No No AP 2017/09/28 EPIC PHARMA LLC
212360 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2019/07/17 CAPLIN
212676 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2019/07/17 PROVEPHARM SAS
209860 001 ANDA TRANEXAMIC ACID TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML Prescription No No AP 2020/01/14 APOTEX
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