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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2300361 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(2.4) New Drug Application 2023-04-11 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd view
CXHS1400200 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2014-10-22 上海汇伦江苏药业有限公司 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd Certificate Issued 2016-03-11 view
CXHS1400201 西维来司他钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2014-10-22 上海汇伦江苏药业有限公司 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd Certificate Issued 2016-09-11 view
CYHB2007727 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3) Supplementary Application 2020-10-15 上海汇伦江苏药业有限公司 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd In Review 2020-10-14 view
CYHB2100247 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3) Supplementary Application 2021-02-11 上海汇伦江苏药业有限公司,苏州二叶制药有限公司 Certificate Issued 2021-10-20 view
CYHS2000102 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3) Generic Drug 2020-02-14 上海汇伦江苏药业有限公司 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd Certificate Issued 2020-03-13 view
X0302401 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2003-05-11 中国医学科学院药物研究所 Institute of Materia Medica Chinese Academy of Medical Sciences Certificate Completed-Pending Issued 2003-05-19 view
X0302402 注射用西维来司钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2003-05-11 中国医学科学院药物研究所 Institute of Materia Medica Chinese Academy of Medical Sciences Certificate Completed-Pending Issued 2003-05-19 view
X0302699 西维来司他钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2003-05-28 重庆医药工业研究院有限责任公司 Chongqing Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-01-14 view
X0302700 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2003-05-28 重庆医药工业研究院有限责任公司 Chongqing Pharmaceutical Research Institute Co Ltd Certificate Issued 2004-01-14 view
X0302712 西维来司他钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-03-24 北京德众万全药物技术开发有限公司 Beijing Dezhong Wanquan Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-07-02 view
X0302713 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-03-24 北京德众万全药物技术开发有限公司 Beijing Dezhong Wanquan Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-07-02 view
X0302726 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-03-23 赤峰市博达药物研究所 Chifeng Boda Pharmaceutical Research Institute Certificate Issued 2004-07-05 view
X0302727 注射用西维来司钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-03-23 赤峰市博达药物研究所 Chifeng Boda Pharmaceutical Research Institute Certificate Issued 2004-07-05 view
X0302943 注射用西维来司他 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-02-03 南昌弘益科技有限公司 Nanchang Hongyi Technology Co Ltd Certificate Issued 2004-06-18 view
X0302958 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-04-07 海南普利制药有限公司 Hainan Poly Pharm Co Ltd Certificate Issued 2004-08-10 view
X0302959 注射用西维来司钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-04-07 海南普利制药有限公司 Hainan Poly Pharm Co Ltd Certificate Issued 2004-08-10 view
X0303031 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-04-07 中国科学院上海药物研究所 Shanghai Institute of Materia Medica Chinese Academy of Sciences Certificate Issued 2004-07-05 view
X0303032 注射用西维来司钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-04-07 中国科学院上海药物研究所 Shanghai Institute of Materia Medica Chinese Academy of Sciences Certificate Issued 2004-07-05 view
X0303134 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-09-20 南京华威医药科技开发有限公司 Nanjing Huawei Medicine Technology Development Co Ltd Certificate Issued 2004-12-31 view