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=NDA201848"
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
75833-601-01 75833-601 HUMAN PRESCRIPTION DRUG Hepzato Kit melphalan hydrochloride injection, powder, lyophilized, for solution KIT INTRA-ARTERIAL 20231204 N/A NDA NDA201848 Delcath Systems, Inc. 1 KIT in 1 BOX (75833-601-01) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE
75833-601-02 75833-601 HUMAN PRESCRIPTION DRUG Hepzato Kit melphalan hydrochloride injection, powder, lyophilized, for solution KIT INTRA-ARTERIAL 20231204 N/A NDA NDA201848 Delcath Systems, Inc. 1 KIT in 1 BOX (75833-601-02) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE
75833-601-07 75833-601 HUMAN PRESCRIPTION DRUG Hepzato Kit melphalan hydrochloride injection, powder, lyophilized, for solution KIT INTRA-ARTERIAL 20231204 N/A NDA NDA201848 Delcath Systems, Inc. 1 KIT in 1 BOX (75833-601-07) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE
75833-601-08 75833-601 HUMAN PRESCRIPTION DRUG Hepzato Kit melphalan hydrochloride injection, powder, lyophilized, for solution KIT INTRA-ARTERIAL 20231204 N/A NDA NDA201848 Delcath Systems, Inc. 1 KIT in 1 BOX (75833-601-08) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE
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