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=ANDA217957"
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
72843-591-99 72843-591 HUMAN PRESCRIPTION DRUG leuprolide acetate leuprolide acetate KIT SUBCUTANEOUS 20241025 N/A ANDA ANDA217957 UBI Pharma Inc. 1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
83634-454-61 83634-454 HUMAN PRESCRIPTION DRUG Leuprolide Acetate leuprolide acetate KIT SUBCUTANEOUS 20250315 N/A ANDA ANDA217957 Avenacy Inc. 1 KIT in 1 CARTON (83634-454-61) * 1 mL in 1 PACKET (83634-453-01) * 2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03)
0121-2106-02 0121-2106 HUMAN PRESCRIPTION DRUG leuprolide acetate leuprolide acetate KIT SUBCUTANEOUS 20250201 N/A ANDA ANDA217957 PAI Holdings, LLC dba PAI Pharma 1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01)
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