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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHB2050572 注射用泮托拉唑钠 pantoprazole sodium Lyophilized Chemical Drugs(原6) Supplementary Application 2020-09-24 山东罗欣药业集团股份有限公司,山东裕欣药业有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd;Shandong YUXIN Pharmaceutical Co Ltd Certificate Issued 2021-10-18 view
CXHL1502501 SCC-31 SCC-31 Active ingredient Chemical Drugs(1.1) New Drug Application 2016-02-16 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-09-04 view
CYHB2050487 注射用盐酸头孢替安 cefotiam hydrochloride Lyophilized Chemical Drugs(原6) Supplementary Application 2020-08-12 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd In Review 2020-08-11 view
CXHL1500655 奥拉帕尼 olaparib Active ingredient Chemical Drugs(3.1) New Drug Application 2015-05-15 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-08-04 view
CYHB1950514 盐酸氨溴索注射液 ambroxol hydrochloride Injection Chemical Drugs Supplementary Application 2019-07-19 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2020-12-07 view
CXHL1401859 盐酸美金刚缓释胶囊 memantine hydrochloride Capsules, extended release Chemical Drugs(5) New Drug Application 2015-02-28 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-10-11 view
CYHB1801456 注射用三磷酸胞苷二钠 cytidine disodium triphosphate Lyophilized Chemical Drugs Supplementary Application 2018-03-30 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2018-07-13 view
CYHB1706505 注射用头孢硫脒 Cefathiamidine Lyophilized Chemical Drugs Supplementary Application 2017-10-31 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2018-03-26 view
CYHB2150018 注射用美罗培南 meropenem Lyophilized Chemical Drugs(原6) Supplementary Application 2021-01-09 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2022-01-14 view
CYHS1400904 苯磺顺阿曲库铵 cisatracurium besilate Active ingredient Chemical Drugs(6) Generic Drug 2015-07-07 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2017-08-29 view
CXHL2000073 LX-086片 LX-086 Tablet Chemical Drugs(1) New Drug Application 2020-03-06 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd;Luoxin Pharmaceutical (Shanghai) Co Ltd In Review 2020-03-04 view
CXHL1402286 磷酸特地唑胺 tedizolid phosphate Active ingredient Chemical Drugs(3.1) New Drug Application 2015-03-19 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-05-19 view
CYHB1850358 头孢拉定胶囊 cefradine Capsule Chemical Drugs Supplementary Application 2018-11-30 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2019-11-22 view
CXHL1401647 枸橼酸托法替布片 tofacitinib citrate Tablet Chemical Drugs(3.1) New Drug Application 2014-12-31 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-04-21 view
CXHL1501335 依帕列净利格列汀片 empagliflozin;linagliptin Tablet Chemical Drugs(3.2) New Drug Application 2015-12-30 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-12-08 view
CYHB2050459 注射用头孢美唑钠 cefmetazole sodium Lyophilized Chemical Drugs(原6) Supplementary Application 2020-08-01 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2021-09-23 view
CXHL1401299 碳酸司维拉姆干混悬剂 sevelamer carbonate Suspension Chemical Drugs(3.1) New Drug Application 2014-10-28 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-08-04 view
CXHL1500474 磷酸特地唑胺片 tedizolid phosphate Tablet Chemical Drugs(3.1) New Drug Application 2015-05-15 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-08-04 view
CXHL1900040 LX-039片 LX-039 Tablet Chemical Drugs(1) New Drug Application 2019-01-26 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd;Luoxin Pharmaceutical (Shanghai) Co Ltd In Review 2019-01-24 view
CYHB1407523 注射用头孢西酮钠 CEFAZEDONE SODIUM Lyophilized Chemical Drugs Supplementary Application 2015-02-13 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-11-23 view