美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=RANEXA"
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
TRANEXAMIC ACID 206594 001 ANDA TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML No No 2017/09/28 2017/09/28 EPIC PHARMA LLC Discontinued
TRANEXAMIC ACID 212020 001 NDA TRANEXAMIC ACID SOLUTION;INTRAVENOUS 1GM/100ML (10MG/ML) Yes Yes 2019/04/15 2019/04/15 EXELA PHARMA Prescription
TRANEXAMIC ACID 212360 001 ANDA TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML No No 2019/07/17 2019/07/17 CAPLIN Prescription
TRANEXAMIC ACID 212676 001 ANDA TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML No No 2019/07/17 2019/07/17 PROVEPHARM SAS Prescription
TRANEXAMIC ACID 209860 001 ANDA TRANEXAMIC ACID INJECTABLE;INJECTION 100MG/ML No No 2020/01/14 2020/01/14 APOTEX Prescription
TRANEXAMIC ACID 217155 001 ANDA TRANEXAMIC ACID SOLUTION;INTRAVENOUS 1GM/100ML (10MG/ML) No No 2023/10/16 2023/10/16 AMNEAL Prescription
TRANEXAMIC ACID 216877 001 ANDA TRANEXAMIC ACID SOLUTION;INTRAVENOUS 1GM/100ML (10MG/ML) No No 2024/04/16 -- NEXUS Prescription
TRANEXAMIC ACID 218599 001 ANDA TRANEXAMIC ACID SOLUTION;INTRAVENOUS 1GM/100ML (10MG/ML) No No 2024/04/16 -- GLAND PHARMA LTD Prescription
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