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=ANDA212791"
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
72572-128-08 72572-128 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTION INTRAVENOUS 20210823 N/A ANDA ANDA212791 CIVICA, INC. DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 8 BOTTLE in 1 CARTON (72572-128-08) / 100 mL in 1 BOTTLE (72572-128-01)
71225-133-02 71225-133 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTION INTRAVENOUS 20211020 N/A ANDA ANDA212791 Slayback Pharma LLC DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 8 BOTTLE in 1 CARTON (71225-133-02) / 100 mL in 1 BOTTLE (71225-133-01)
72572-127-10 72572-127 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTION INTRAVENOUS 20210823 N/A ANDA ANDA212791 CIVICA, INC. DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 BOTTLE in 1 CARTON (72572-127-10) / 50 mL in 1 BOTTLE (72572-127-01)
71225-132-02 71225-132 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTION INTRAVENOUS 20211020 N/A ANDA ANDA212791 Slayback Pharma LLC DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 BOTTLE in 1 CARTON (71225-132-02) / 50 mL in 1 BOTTLE (71225-132-01)
71225-126-04 71225-126 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTION INTRAVENOUS 20211211 N/A ANDA ANDA212791 Slayback Pharma LLC DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 VIAL in 1 CARTON (71225-126-04) / 20 mL in 1 VIAL (71225-126-01)
71225-126-05 71225-126 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTION INTRAVENOUS 20191206 N/A ANDA ANDA212791 Slayback Pharma LLC DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 20 BOTTLE in 1 CARTON (71225-126-05) / 50 mL in 1 BOTTLE (71225-126-02)
71225-126-06 71225-126 HUMAN PRESCRIPTION DRUG DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTION INTRAVENOUS 20191206 N/A ANDA ANDA212791 Slayback Pharma LLC DEXMEDETOMIDINE HYDROCHLORIDE 4 ug/mL 10 BOTTLE in 1 CARTON (71225-126-06) / 100 mL in 1 BOTTLE (71225-126-03)
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