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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHS0601522 托吡酯片 topiramate Tablet Chemical Drugs(3.4) New Drug Application 2007-04-10 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Certificate Issued 2009-07-31 view
JYHB1701547 草酸艾司西酞普兰片 escitalopram oxalate Tablet Chemical Drugs Supplementary Application 2017-12-11 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;HLundbeck A/S Filed 2017-12-20 view
JYHB1900285 硝酸咪康唑阴道软胶囊 miconazole nitrate Soft capsules Chemical Drugs Supplementary Application 2019-03-06 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;CataIent France Beinheim SA;Janssen-Cilag NV Certificate Issued 2020-02-24 view
JYHB2000609 达芦那韦考比司他片 cobicistat;darunavir Tablet Chemical Drugs Supplementary Application 2020-05-21 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Janssen Ortho LLC;Janssen-Cilag International NV Filed 2020-06-01 view
JYSB1300108 重组乙型肝炎疫苗(汉逊酵母) Recombinant Hepatitis B Vaccine(Hansenula Polymorpha) Injection Biological Products Supplementary Application 2013-06-18 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Berna Biotech Korea Corp Certificate Issued 2014-10-27 view
H20010247 盐酸氟桂利嗪 flunarizine hydrochloride Active ingredient Chemical Drugs Import Drug Application 2001-11-07 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Approval Completed-Pending Certificated view
JYHB1700928 帕利哌酮缓释片 paliperidone Tablet, extended release Chemical Drugs Supplementary Application 2017-07-01 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Janssen-Cilag International NV;Janssen Cilag Manufacturing LLC Filed 2017-07-25 view
JYHB1800925 利培酮口服液 risperidone Oral solution Chemical Drugs Supplementary Application 2018-08-09 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Johnson & Johnson Innovative Medicine;Janssen-Cilag NV Certificate Issued 2019-03-28 view
JXHL1200058 注射用硼替佐米 bortezomib Lyophilized Chemical Drugs Import Drug Application 2012-03-21 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Janssen-Cilag International NV Certificate Issued 2013-01-31 view
JYHB2000491 注射用利培酮微球 risperidone Lyophilized Chemical Drugs Supplementary Application 2020-04-20 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Janssen-Cilag AG Filed 2020-04-28 view
JYHB2100130 盐酸哌甲酯缓释片 methylphenidate hydrochloride Tablet, extended release Chemical Drugs Supplementary Application 2021-02-06 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Janssen Pharmaceuticals Inc;Janssen Cilag Manufacturing LLC In Review 2021-02-05 view
J0402443 骨架扩散型芬太尼透皮贴剂 fentanyl Patch Chemical Drugs(3.1) Import Drug Application 2004-12-22 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Approval Completed-Pending Certificated 2006-09-18 view
JYHB1700699 帕利哌酮缓释片 paliperidone Tablet, extended release Chemical Drugs Supplementary Application 2017-05-22 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Janssen-Cilag International NV;Janssen Cilag Manufacturing LLC Certificate Issued 2017-09-14 view
JYHB1800159 利培酮口服液 risperidone Oral solution Chemical Drugs Supplementary Application 2018-02-26 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Johnson & Johnson Innovative Medicine;Janssen-Cilag NV Certificate Issued 2018-05-21 view
CXHR0900222 托吡酯片 topiramate Tablet Chemical Drugs State Standards 2009-10-13 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Certificate Issued 2010-11-17 view
CYHB1905222 伊曲康唑胶囊 itraconazole Capsule Chemical Drugs Supplementary Application 2019-09-21 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Certificate Issued 2020-11-05 view
JYSB2000516 乌司奴单抗注射液 ustekinumab Injection Biological Products Supplementary Application 2020-10-15 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Cilag AG;Janssen-Cilag International NV Certificate Issued 2021-08-17 view
AS20010013 注射用因福利美 infliximab Lyophilized Biological Products New Drug Application 2003-09-19 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd Approval Completed-Pending Certificated 2003-12-17 view
JYSB1500077 注射用英夫利西单抗 infliximab Lyophilized Biological Products Supplementary Application 2015-04-10 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Janssen Biologics BV;Cilag AG Certificate Issued 2015-09-11 view
JYHB0700572 TMC278 rilpivirine Active ingredient Chemical Drugs Supplementary Application 2007-05-24 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Johnson & Johnson Innovative Medicine Certificate Issued 2007-11-15 view