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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
CYHS1500262 依诺肝素钠注射液 enoxaparin sodium Injection Chemical Drugs(6) Generic Drug 2015-09-06 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2017-06-20 view
CXSL0500061 重组人粒细胞巨噬细胞集落刺激因子喷雾剂 Spray Biological Products(13) New Drug Application 2005-07-18 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2006-09-06 view
CYSB1900415 重组人促红素注射液(CHO细胞) Human Erythropoietin Injection Biological Products Supplementary Application 2019-12-13 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2020-07-29 view
CYSB1700225 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2018-06-15 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2019-01-08 view
CYSB1100478 注射用重组人粒细胞巨噬细胞刺激因子 Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Lyophilized Biological Products Supplementary Application 2012-02-22 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2012-07-17 view
CYSB1900354 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2019-10-21 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2020-02-20 view
CYHS1402067 那屈肝素钙注射液 nadroparin calcium Injection Chemical Drugs(6) Generic Drug 2015-07-13 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2017-06-20 view
CYSB0500007 重组人粒细胞集落刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2005-02-22 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2005-08-03 view
CYSB1900404 重组乙型肝炎疫苗(CHO细胞) Recombinant Hepatitis B Vaccine(CHO Cell) Injection Biological Products Supplementary Application 2019-12-13 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2020-03-17 view
CYSB1500267 重组乙型肝炎疫苗(CHO细胞) Recombinant Hepatitis B Vaccine(CHO Cell) Injection Biological Products Supplementary Application 2016-02-26 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2017-03-30 view
CYSB0900026 重组乙型肝炎疫苗(CHO细胞) Recombinant Hepatitis B Vaccine(CHO Cell) Injection Biological Products Supplementary Application 2009-06-04 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2010-02-05 view
CXSS2000039 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 NCPC Genetech BIOTECHNOLOGY Co Ltd In Review 2020-07-02 view
CYSB1900350 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2019-10-21 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2020-02-20 view
CYSB1400111 重组人促红素注射液(CHO细胞) Human Erythropoietin Injection Biological Products Supplementary Application 2014-08-04 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2015-04-08 view
CYSB1900408 重组人促红素注射液(CHO细胞) Human Erythropoietin Injection Biological Products Supplementary Application 2019-12-13 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2020-02-26 view
CYSB1900414 重组人促红素注射液(CHO细胞) Human Erythropoietin Injection Biological Products Supplementary Application 2019-12-13 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2020-07-29 view
CYSB1700224 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2018-06-15 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2019-01-08 view
CYSB1100476 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2012-02-22 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2012-07-17 view
CYSB1900353 重组人粒细胞刺激因子注射液 Granulocyte colony-stimulating factor receptor Injection Biological Products Supplementary Application 2019-10-21 华北制药金坦生物技术股份有限公司 NCPC Genetech BIOTECHNOLOGY Co Ltd Certificate Issued 2020-02-20 view