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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB2400093 SH006注射液 SH-006 Injection Biological Products(1) Supplementary Application 2024-08-30 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
CXHL2300978 SHC014748M胶囊 SHC-014748M Capsule Chemical Drugs(1) New Drug Application 2023-09-12 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
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
CXHL2200431 SH-1028片 Oritinib mesylate Tablet Chemical Drugs(1) New Drug Application 2022-06-28 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
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
CXSL2101463 SH006注射液 SH-006 Injection Biological Products(1) New Drug Application 2021-12-06 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
CXHL2000598 SH3809片 SH3809 Tablet Chemical Drugs(1) New Drug Application 2020-11-26 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2020-11-25 view
CXHL2000599 SH3809片 SH3809 Tablet Chemical Drugs(1) New Drug Application 2020-11-26 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2020-11-25 view
CXHS2000042 和乐布韦片 alfosbuvir Tablet Chemical Drugs(1) New Drug Application 2020-11-17 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2020-11-16 view
CYHS2000729 盐酸达拉他韦片 daclatasvir dihydrochloride Tablet Chemical Drugs(4) Generic Drug 2020-10-17 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2020-10-16 view
CYHB2006845 奥硝唑注射液 ornidazole Injection Chemical Drugs(原4) Supplementary Application 2020-09-12 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2020-09-11 view
CYHS2000327 注射用阿奇霉素 azithromycin Lyophilized Chemical Drugs(4) Generic Drug 2020-05-18 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2021-07-05 view
CYHB2002590 左奥硝唑氯化钠注射液 levornidazole Injection Chemical Drugs Supplementary Application 2020-05-06 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2020-05-01 view
CYHB2040010 注射用帕瑞昔布钠 parecoxib sodium Lyophilized Chemical Drugs Supplementary Application 2020-03-25 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2021-01-12 view
CYHB2040009 注射用帕瑞昔布钠 parecoxib sodium Lyophilized Chemical Drugs Supplementary Application 2020-03-25 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2021-01-12 view
CYHB1950955 奥硝唑片 ornidazole Tablet Chemical Drugs Supplementary Application 2020-01-07 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2020-01-06 view