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=ANDA202126"
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
57664-596-50 57664-596 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20150408 N/A ANDA ANDA202126 Sun Pharmaceuticals Industries, Inc. DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL 25 VIAL, SINGLE-DOSE in 1 CARTON (57664-596-50) / 2 mL in 1 VIAL, SINGLE-DOSE (57664-596-40)
68083-527-25 68083-527 HUMAN PRESCRIPTION DRUG Dexmedetomidine Dexmedetomidine INJECTION, SOLUTION INTRAVENOUS 20210628 N/A ANDA ANDA202126 Gland Pharma Limited DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL 25 VIAL in 1 CARTON (68083-527-25) / 2 mL in 1 VIAL
66794-233-42 66794-233 HUMAN PRESCRIPTION DRUG Dexmedetomidine Dexmedetomidine INJECTION, SOLUTION INTRAVENOUS 20210501 N/A ANDA ANDA202126 Piramal Critical Care Inc DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/2mL 25 VIAL, GLASS in 1 CARTON (66794-233-42) / 2 mL in 1 VIAL, GLASS (66794-233-02)
66794-230-42 66794-230 HUMAN PRESCRIPTION DRUG Dexmedetomidine Dexmedetomidine INJECTION, SOLUTION INTRAVENOUS 20210119 N/A ANDA ANDA202126 Piramal Critical Care Inc DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/2mL 25 VIAL, GLASS in 1 CARTON (66794-230-42) / 2 mL in 1 VIAL, GLASS (66794-230-02)
71872-7323-1 71872-7323 HUMAN PRESCRIPTION DRUG Dexmedetomidine Dexmedetomidine INJECTION, SOLUTION INTRAVENOUS 20240122 N/A ANDA ANDA202126 Medical Purchasing Solutions, LLC DEXMEDETOMIDINE HYDROCHLORIDE 200 ug/2mL 1 VIAL, GLASS in 1 BAG (71872-7323-1) / 2 mL in 1 VIAL, GLASS
71872-7122-1 71872-7122 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20180330 N/A ANDA ANDA202126 Medical Purchasing Solutions, LLC DEXMEDETOMIDINE HYDROCHLORIDE 100 ug/mL 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7122-1) / 2 mL in 1 VIAL, SINGLE-DOSE
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