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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXb20020367 酒石酸唑吡坦片剂 zolpidem tartrate Tablet Chemical Drugs(4) Supplementary Application 2002-07-01 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2003-07-21 view
X0300223 硫辛酸 Other Chemical Drugs(3.1) New Drug Application 2003-01-21 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2003-10-10 view
X0300225 硫辛酸胶丸 Soft capsules Chemical Drugs(3.1) New Drug Application 2003-01-21 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2003-10-10 view
X0300224 硫辛酸注射液 Injection Chemical Drugs(3.1) New Drug Application 2003-01-21 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2003-10-10 view
Y0300722 阿奇霉素干混悬剂 azithromycin Suspension Chemical Drugs(6) Generic Drug 2003-03-20 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2003-09-04 view
X0303048 硫辛酸胶丸 Soft capsules Chemical Drugs Supplementary Application 2003-07-01 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-02-13 view
X0303241 硝苯地平控释片 nifedipine Tablet, extended release Chemical Drugs Supplementary Application 2003-07-07 上海现代制药股份有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-04-16 view
X0303250 头孢拉定分散片 cefradine Tablet Chemical Drugs Supplementary Application 2003-07-07 上海现代制药股份有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2003-12-05 view
X0304074 辛伐他汀干混悬剂 simvastatin Suspension Chemical Drugs(5) New Drug Application 2003-08-09 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-04-09 view
X0304894 阿德福韦酯胶囊 adefovir dipivoxil Capsule Chemical Drugs(3.1) New Drug Application 2003-09-19 上海现代制药股份有限公司 Shanghai Shyndec Pharmaceutical Co Ltd;Shanghai Institute of Pharmaceutical Industry Certificate Issued 2004-04-09 view
X0304893 阿德福韦酯 adefovir dipivoxil Active ingredient Chemical Drugs(3.1) New Drug Application 2003-09-19 上海现代制药股份有限公司 Shanghai Shyndec Pharmaceutical Co Ltd;Shanghai Institute of Pharmaceutical Industry Certificate Issued 2004-04-09 view
Y0304483 门冬氨酸钾镁片 Magnesium aspartate;Potassium Aspartate Tablet Chemical Drugs Supplementary Application 2003-11-05 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-06-11 view
Y0400626 阿奇霉素干混悬剂 azithromycin Suspension Chemical Drugs(6) Generic Drug 2004-02-09 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-10-12 view
Y0401466 硫辛酸 Other Chemical Drugs(6) Generic Drug 2004-03-16 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-11-05 view
X0402648 头孢克洛缓释胶囊 cefaclor Capsules, extended release Chemical Drugs Supplementary Application 2004-05-19 上海现代制药股份有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2005-01-27 view
Y0304335 联苯苄唑乳膏 bifonazole Cream Chemical Drugs(6) Generic Drug 2004-06-03 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2005-06-08 view
Y0410529 克拉霉素 clarithromycin Active ingredient Chemical Drugs(6) Generic Drug 2004-09-16 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2005-08-31 view
X0400030 普卢利沙星片 prulifloxacin Tablet Chemical Drugs(3.1) New Drug Application 2004-09-17 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-12-16 view
X0400029 普卢利沙星 prulifloxacin Active ingredient Chemical Drugs(3.1) New Drug Application 2004-09-17 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2004-12-16 view
Y0410677 克拉霉素片 clarithromycin Tablet Chemical Drugs(6) Generic Drug 2004-09-23 上海现代浦东药厂有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2005-10-13 view