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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
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
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
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
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
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
X0304038 西维来司他钠水合物 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-12-22 桂林南药股份有限公司 Guilin Pharmaceutical Co Ltd Certificate Issued 2005-04-04 view
X0304039 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-12-22 桂林南药股份有限公司 Guilin Pharmaceutical Co Ltd Certificate Issued 2005-04-04 view
X0303604 注射用西维来司钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-12-06 济南百诺医药科技开发有限公司 Shandong Bestcomm Pharmaceutical Company Limited Certificate Issued 2005-02-25 view
X0303603 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-12-06 济南百诺医药科技开发有限公司 Shandong Bestcomm Pharmaceutical Company Limited Certificate Issued 2005-02-25 view
X0303145 西维来司他钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-11-18 湖北麒麟生物科技发展有限公司 Hubei Qilin Biotechnology Development Co Ltd Certificate Issued 2005-02-08 view
X0303146 注射用西维来司他钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-11-18 湖北麒麟生物科技发展有限公司 Hubei Qilin Biotechnology Development Co Ltd Certificate Issued 2005-02-08 view
X0305138 注射用西维来司钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-11-12 扬州奥赛康药业有限公司 Yangzhou Aosaikang Pharmaceutical Co Ltd Certificate Issued 2005-03-23 view
X0305137 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-11-12 扬州制药有限公司 Yangzhou Pharmaceutical Co Ltd Certificate Issued 2005-03-23 view
X0305139 西维来司钠注射液 sivelestat sodium Injection Chemical Drugs(3.1) New Drug Application 2004-11-12 扬州制药有限公司 Yangzhou Pharmaceutical Co Ltd Certificate Issued 2005-03-23 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
X0303135 注射用西维来司钠 sivelestat sodium Lyophilized 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
X0304919 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-07-09 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2004-10-10 view
X0304920 注射用西维来司钠 sivelestat sodium Lyophilized Chemical Drugs(3.1) New Drug Application 2004-07-09 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2004-10-10 view
X0304776 西维来司钠 sivelestat sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-07-01 湖北潜江制药股份有限公司 Hubei Qianjiang Pharmaceutical Co Ltd Certificate Issued 2004-11-26 view