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=ANDA209826"
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
68083-259-01 68083-259 HUMAN PRESCRIPTION DRUG Melphalan hydrochloride Melphalan hydrochloride KIT 20190610 N/A ANDA ANDA209826 Gland Pharma Limited 1 KIT in 1 CARTON (68083-259-01) * 10 mL in 1 VIAL, SINGLE-USE (68083-261-01) * 10 mL in 1 VIAL, SINGLE-DOSE (68083-260-01)
71288-112-90 71288-112 HUMAN PRESCRIPTION DRUG Melphalan hydrochloride Melphalan hydrochloride KIT INTRAVENOUS 20190630 20250430 ANDA ANDA209826 Meitheal Pharmaceuticals Inc. 1 KIT in 1 CARTON (71288-112-90) * 10 mL in 1 VIAL, SINGLE-DOSE (71288-111-10) * 10 mL in 1 VIAL, SINGLE-USE (71288-110-10)
70860-214-61 70860-214 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride melphalan hydrochloride KIT INTRAVENOUS 20190730 20251031 ANDA ANDA209826 Athenex Pharmaceutical Division, LLC. 1 KIT in 1 CARTON (70860-214-61) * 10 mL in 1 VIAL, SINGLE-DOSE (70860-212-10) * 10 mL in 1 VIAL, SINGLE-USE (70860-213-10)
72266-128-01 72266-128 HUMAN PRESCRIPTION DRUG Melphalan hydrochloride Melphalan hydrochloride KIT 20190923 N/A ANDA ANDA209826 Fosun Pharma USA Inc 1 KIT in 1 CARTON (72266-128-01) * 10 mL in 1 VIAL, SINGLE-DOSE (72266-144-01) * 10 mL in 1 VIAL, SINGLE-USE (72266-145-01)
25021-258-61 25021-258 HUMAN PRESCRIPTION DRUG Melphalan Hydrochloride Melphalan Hydrochloride KIT INTRAVENOUS 20240401 N/A ANDA ANDA209826 Sagent Pharmaceuticals 1 KIT in 1 CARTON (25021-258-61) * 10 mL in 1 VIAL (25021-256-10) * 10 mL in 1 VIAL (25021-257-10)
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