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=ANDA209307"
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
66794-234-44 66794-234 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION INTRAVENOUS 20210401 N/A ANDA ANDA209307 Piramal Critical Care Inc DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 20 VIAL in 1 CARTON (66794-234-44) / 50 mL in 1 VIAL (66794-234-02)
66794-235-41 66794-235 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION INTRAVENOUS 20210401 N/A ANDA ANDA209307 Piramal Critical Care Inc DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 VIAL in 1 CARTON (66794-235-41) / 100 mL in 1 VIAL (66794-235-02)
43598-975-58 43598-975 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20200817 N/A ANDA ANDA209307 Dr.Reddy's Laboratories Inc DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 VIAL in 1 CARTON (43598-975-58) / 100 mL in 1 VIAL (43598-975-11)
43598-976-58 43598-976 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION INTRAVENOUS 20200817 N/A ANDA ANDA209307 Dr.Reddy's Laboratories Inc DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 VIAL in 1 CARTON (43598-976-58) / 50 mL in 1 VIAL (43598-976-11)
68083-238-20 68083-238 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION INTRAVENOUS 20200603 N/A ANDA ANDA209307 Gland Pharma Limited DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 20 VIAL in 1 CARTON (68083-238-20) / 50 mL in 1 VIAL (68083-238-01)
68083-239-10 68083-239 HUMAN PRESCRIPTION DRUG Dexmedetomidine Hydrochloride Dexmedetomidine Hydrochloride INJECTION INTRAVENOUS 20200603 N/A ANDA ANDA209307 Gland Pharma Limited DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 VIAL in 1 CARTON (68083-239-10) / 100 mL in 1 VIAL (68083-239-01)
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