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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2300978 SHC014748M胶囊 SHC-014748M Capsule Chemical Drugs(1) New Drug Application 2023-09-12 Nanjing Sanhome Pharmaceutical CoLtd view
CXSL2101362 SH009注射液 SHS-009 Injection Biological Products(1) New Drug Application 2021-10-14 Nanjing Sanhome Pharmaceutical CoLtd view
CYHB2301957 左奥硝唑氯化钠注射液 levornidazole Injection Chemical Drugs Supplementary Application 2023-08-30 Nanjing Sanhome Pharmaceutical CoLtd view
CXSL2200149 SH010注射液 SH-010 Injection Biological Products(1) New Drug Application 2022-03-31 Nanjing Sanhome Pharmaceutical CoLtd view
CXHL2200431 SH-1028片 Oritinib mesylate Tablet Chemical Drugs(1) New Drug Application 2022-06-28 Nanjing Sanhome Pharmaceutical CoLtd view
CXSB2400093 SH006注射液 SH-006 Injection Biological Products(1) Supplementary Application 2024-08-30 Nanjing Sanhome Pharmaceutical CoLtd view
CYHB2301891 复方氨基酸胶囊(9-5) Arginine hydrochloride;isoleucine;leucine;Lysine Hydrochloride;Methionone;nicotinamide;phenylalanine;pyridoxinium chloride;thiamine;threonine;tocopherol;tryptophan;valine; Capsule Chemical Drugs Supplementary Application 2023-08-23 Nanjing Sanhome Pharmaceutical CoLtd view
CXSL2101463 SH006注射液 SH-006 Injection Biological Products(1) New Drug Application 2021-12-06 Nanjing Sanhome Pharmaceutical CoLtd view
CXHS2300115 甲磺酸瑞厄替尼片 Oritinib mesylate Tablet Chemical Drugs(1) New Drug Application 2023-12-15 Nanjing Sanhome Pharmaceutical CoLtd view
CXHS2101058 甲磺酸奥瑞替尼片 Oritinib mesylate Tablet Chemical Drugs(1) New Drug Application 2021-12-28 Nanjing Sanhome Pharmaceutical CoLtd view
Y0304106 甘油果糖注射液 Fructose;glycerol Injection Chemical Drugs(6) Generic Drug 2004-03-17 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2004-07-12 view
CXHL1000185 左奥硝唑阴道泡腾片 levornidazole Tablet Chemical Drugs(2) New Drug Application 2010-07-09 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2011-04-01 view
CXS20021090 注射用苦参素 marine Lyophilized Chemical Drugs(4) New Drug Application 2002-11-14 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2003-09-27 view
CXHL0500684 头孢唑喃钠 cefuzonam sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2005-04-21 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2006-06-28 view
CXL01D24 加替沙星葡萄糖注射液 gatifloxacin Injection Chemical Drugs(2) New Drug Application 2001-11-19 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Approval Completed-Pending Certificated 2003-01-21 view
X0403007 伏立康唑 voriconazole Active ingredient Chemical Drugs(3.1) New Drug Application 2004-12-20 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2006-07-06 view
X0402911 注射用加替沙星 gatifloxacin Lyophilized Chemical Drugs Supplementary Application 2004-06-03 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2004-09-24 view
CXHL1200137 帕拉米韦三水合物 peramivir Active ingredient Chemical Drugs(3.1) New Drug Application 2012-04-12 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2015-07-01 view
X0304174 注射用奥拉西坦 oxiracetam Lyophilized Chemical Drugs(3.3) New Drug Application 2003-08-13 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2004-03-05 view
CYHB0501743 注射用盐酸甲氯芬酯 meclofenoxate hydrochloride Lyophilized Chemical Drugs Supplementary Application 2005-07-25 南京圣和药业有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2005-11-17 view