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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
CYSB1900416 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
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
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
CYSB1900413 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
CYSB1900418 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
CYSB1900412 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
CYSB1900417 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
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
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
CYSB1900405 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
CYSB1900406 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
CYSB1900411 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
CYSB1900410 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
CYSB1900409 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
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
CYSB1900407 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
CYSB1900351 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
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
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