美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=ANDA203521"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
14593-318-01 14593-318 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20241028 N/A ANDA ANDA203521 Emcure Pharmaceuticals Limited TRANEXAMIC ACID 1 g/10mL 10 VIAL in 1 CARTON (14593-318-01) / 10 mL in 1 VIAL
83634-401-10 83634-401 HUMAN PRESCRIPTION DRUG tranexamic acid tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20240601 N/A ANDA ANDA203521 Avenacy, Inc. TRANEXAMIC ACID 100 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41)
70860-407-10 70860-407 HUMAN PRESCRIPTION DRUG Tranexamic Acid tranexamic acid INJECTION, SOLUTION INTRAVENOUS 20220922 20251231 ANDA ANDA203521 Athenex Pharmaceutical Division, LLC. TRANEXAMIC ACID 100 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (70860-407-10) / 10 mL in 1 VIAL, SINGLE-DOSE (70860-407-41)
23155-166-41 23155-166 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20140813 N/A ANDA ANDA203521 Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. TRANEXAMIC ACID 1 g/10mL 10 VIAL, GLASS in 1 CARTON (23155-166-41) / 10 mL in 1 VIAL, GLASS (23155-166-31)
23155-524-41 23155-524 HUMAN PRESCRIPTION DRUG Tranexamic Acid Tranexamic Acid INJECTION, SOLUTION INTRAVENOUS 20140813 N/A ANDA ANDA203521 Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. TRANEXAMIC ACID 1 g/10mL 10 VIAL, GLASS in 1 CARTON (23155-524-41) / 10 mL in 1 VIAL, GLASS (23155-524-31)
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