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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB1900293 DS-8201a trastuzumab deruxtecan Lyophilized Biological Products Supplementary Application 2019-10-25 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Daiichi Sankyo Co Ltd;Baxter Oncology GmbH Certificate Issued 2019-12-27 view
JYHF1800129 洛索洛芬钠贴剂 loxoprofen sodium Patch Chemical Drugs Supplementary Application 2018-10-25 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Lead Chemical Co Ltd;Lead Chemical Co LtdHisagane Plant Certificate Issued 2018-11-20 view
JYHB2100213 盐酸尼卡地平注射液 nicardipine hydrochloride Injection Chemical Drugs(5.1) Supplementary Application 2021-03-20 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Nipro Pharma Corporation Ise Plant;Ltl Pharma Co Ltd Certificate Issued 2021-07-15 view
JYHB2100197 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(5.1) Supplementary Application 2021-03-12 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Daiichi Sankyo Europe GmbH Certificate Issued 2021-07-09 view
JYHB2100196 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(5.1) Supplementary Application 2021-03-12 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Daiichi Sankyo Europe GmbH Certificate Issued 2021-07-09 view
JYHB2100195 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(5.1) Supplementary Application 2021-03-12 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Daiichi Sankyo Europe GmbH Certificate Issued 2021-07-09 view
JYHB2002269 盐酸尼卡地平注射液 nicardipine hydrochloride Injection Chemical Drugs(5.1) Supplementary Application 2020-11-11 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Nipro Pharma Corporation Ise Plant;Ltl Pharma Co Ltd Filed 2020-11-24 view
JYHB2002110 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(5.1) Supplementary Application 2020-10-22 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Daiichi Sankyo Europe GmbH Filed 2020-11-05 view
JYHB2002109 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(5.1) Supplementary Application 2020-10-22 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Daiichi Sankyo Europe GmbH Filed 2020-11-05 view
JYHB2002108 甲苯磺酸艾多沙班片 Edoxaban Tosilate Tablet Chemical Drugs(5.1) Supplementary Application 2020-10-22 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Daiichi Sankyo Europe GmbH Filed 2020-11-05 view
JYHB2002033 洛索洛芬钠贴剂 loxoprofen sodium Patch Chemical Drugs Supplementary Application 2020-10-17 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Lead Chemical Co Ltd;Lead Chemical Co LtdHisagane Plant Filed 2020-11-02 view
JYHB2002032 洛索洛芬钠贴剂 loxoprofen sodium Patch Chemical Drugs Supplementary Application 2020-10-17 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Lead Chemical Co Ltd;Lead Chemical Co LtdHisagane Plant Filed 2020-11-02 view
JYHB2000235 洛索洛芬钠贴剂 loxoprofen sodium Patch Chemical Drugs Supplementary Application 2020-03-09 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Lead Chemical Co Ltd;Lead Chemical Co LtdHisagane Plant In Review 2020-03-07 view
JYHB2000234 洛索洛芬钠贴剂 loxoprofen sodium Patch Chemical Drugs Supplementary Application 2020-03-09 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Lead Chemical Co Ltd;Lead Chemical Co LtdHisagane Plant In Review 2020-03-07 view
JYHB2000233 洛索洛芬钠贴剂 loxoprofen sodium Patch Chemical Drugs Supplementary Application 2020-03-18 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Lead Chemical Co Ltd;Lead Chemical Co LtdHisagane Plant In Review 2020-03-17 view
JYHB2000232 洛索洛芬钠贴剂 loxoprofen sodium Patch Chemical Drugs Supplementary Application 2020-03-18 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Lead Chemical Co Ltd;Lead Chemical Co LtdHisagane Plant In Review 2020-03-17 view
JYHB2000040 盐酸尼卡地平注射液 nicardipine hydrochloride Injection Chemical Drugs Supplementary Application 2020-01-17 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Nipro Pharma Corporation Ise Plant;Ltl Pharma Co Ltd Certificate Issued 2020-02-17 view
JYHB1901652 盐酸尼卡地平注射液 nicardipine hydrochloride Injection Chemical Drugs Supplementary Application 2020-01-01 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Nipro Pharma Corporation Ise Plant;Astellas Pharma Inc Filed 2020-01-13 view
JYHB1901651 盐酸尼卡地平注射液 nicardipine hydrochloride Injection Chemical Drugs Supplementary Application 2020-01-01 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Nipro Pharma Corporation Ise Plant;Astellas Pharma Inc Filed 2020-01-13 view
JYHB1901623 PLX3397 HCl胶囊 pexidartinib hydrochloride Capsule Chemical Drugs(5.1) Supplementary Application 2020-01-01 第一三共(中国)投资有限公司 Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Catalent Cts LLC;Daiichi Sankyo Co Ltd In Review 2019-12-31 view