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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2000040 重组人源抗狂犬病毒单抗注射液 Ormutivimab Injection Biological Products(1) New Drug Application 2020-07-04 华北制药金坦生物技术股份有限公司,华北制药集团新药研究开发有限责任公司 Certificate Issued 2021-08-13 view
CXL20020517 依达拉奉注射液 edaravone Injection Chemical Drugs(2) New Drug Application 2002-03-26 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2003-12-05 view
CYHS0890144 咪唑立宾片 mizoribine Tablet Chemical Drugs(6) Generic Drug 2008-07-15 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2009-09-03 view
CYHS0600923 注射用三磷酸胞苷二钠 cytidine disodium triphosphate Lyophilized Chemical Drugs(6) Generic Drug 2006-03-31 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2007-02-08 view
CXHS0501126 注射用曲克芦丁脑蛋白水解物 Lyophilized Chemical Drugs(5) New Drug Application 2005-07-10 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2006-11-02 view
X0404306 普伐他汀钠片 pravastatin sodium Tablet Chemical Drugs New Drug Application 2004-08-01 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2005-04-19 view
CXSL1500032 重组人源抗人肿瘤坏死因子(TNF-α)单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2015-05-13 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2017-02-13 view
CXHB0601335 西罗莫司胶囊 sirolimus Capsule Chemical Drugs Supplementary Application 2006-09-14 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2007-04-25 view
CXHL0501975 辛伐他汀口腔崩解片 Simvastatin Tablet Chemical Drugs(5) New Drug Application 2005-11-20 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2006-08-09 view
Y0403086 吗替麦考酚酯 mycophenolate mofetil Active ingredient Chemical Drugs(6) Generic Drug 2005-01-06 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2005-05-27 view
CXSL0700014 重组人源抗狂犬病毒单抗注射液 Ormutivimab Injection Biological Products(1) New Drug Application 2008-03-04 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2009-07-09 view
CYHS0600392 咪唑立宾 mizoribine Active ingredient Chemical Drugs(6) Generic Drug 2006-03-01 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2008-03-28 view
CYHS0502328 他克莫司胶囊 tacrolimus Capsule Chemical Drugs(6) Generic Drug 2005-05-31 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2006-04-28 view
X0303690 盐酸阿霉素脂质体注射液 doxorubicin hydrochloride Injection Chemical Drugs(5) New Drug Application 2004-06-18 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2007-06-30 view
CYHS0900925 注射用替考拉宁 teicoplanin Lyophilized Chemical Drugs(6) Generic Drug 2010-04-01 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2012-12-19 view
CXHL0600811 甲磺酸左旋多沙唑嗪 Active ingredient Chemical Drugs(1.3) New Drug Application 2006-09-05 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2011-01-27 view
CXHL0501585 西罗莫司胶囊 sirolimus Capsule Chemical Drugs(5) New Drug Application 2005-10-16 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2006-07-04 view
X0406027 吗替麦考酚酯分散片 mycophenolate mofetil Tablet Chemical Drugs(5) New Drug Application 2004-10-25 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2005-09-06 view
CYSB1800075 重组人源抗狂犬病毒单抗注射液 Ormutivimab Injection Biological Products Supplementary Application 2018-04-27 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2018-07-13 view
CYHS0603734 注射用盐酸万古霉素 vancomycin hydrochloride Lyophilized Chemical Drugs(6) Generic Drug 2006-11-22 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2009-05-06 view