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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL0600514 麦考酚钠肠溶片 mycophenolate sodium Tablet Chemical Drugs(3.1) New Drug Application 2006-06-09 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 2008-09-27 view
CXHL0600513 麦考酚钠 mycophenolate sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2006-06-09 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 2008-09-27 view
X0403019 雷帕霉素口服液 sirolimus Oral solution Chemical Drugs New Drug Application 2004-12-15 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 2005-05-09 view
X0403018 雷帕霉素 sirolimus Active ingredient Chemical Drugs New Drug Application 2004-12-15 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 2005-05-09 view
CXSL1600086 重组抗人血管内皮生长因子单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2016-11-17 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 2017-07-06 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
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
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
CXSL0700013 重组人源抗狂犬病毒单抗注射液 Ormutivimab Injection Biological Products(1) New Drug Application 2007-11-11 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
CYSB1800076 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
CXSL1700183 重组人源抗狂犬病毒单抗NM57S/NC08注射液组合制剂 Injection Biological Products(1) New Drug Application 2018-02-06 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 In Review 2018-02-05 view
CXSL1700184 重组人源抗狂犬病毒单抗NM57S/NC08注射液组合制剂 Injection Biological Products(1) New Drug Application 2018-02-06 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 In Review 2018-02-05 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
CSb20020006 重组(CHO细胞)乙型肝炎疫苗(原名:乙肝基因工程疫苗(CHO)) Recombinant Hepatitis B Vaccine(CHO Cell) Injection Biological Products(1) Supplementary Application 2002-02-19 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 2002-06-11 view
CYHS0509054 那他霉素滴眼液 natamycin Eye drops Chemical Drugs(6) Generic Drug 2006-01-10 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 2008-05-09 view
CYHS0509053 那他霉素滴眼液 natamycin Eye drops Chemical Drugs(6) Generic Drug 2006-01-10 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 2008-05-09 view
CXHS0503142 那他霉素 natamycin Active ingredient Chemical Drugs(3.1) New Drug Application 2006-01-10 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 2008-08-19 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
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
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