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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1200174 多利培南 doripenem Active ingredient Chemical Drugs(3.1) New Drug Application 2012-07-23 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2015-10-13 view
CXHL1200175 注射用多利培南 doripenem Lyophilized Chemical Drugs(3.1) New Drug Application 2012-07-23 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2015-10-20 view
CXHL1600210 BC0335 BC0335 Active ingredient Chemical Drugs(1) New Drug Application 2016-09-28 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2017-06-14 view
CXHL1600211 BC0335颗粒 BC0335 Granule Chemical Drugs(1) New Drug Application 2016-09-28 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2017-06-14 view
CXHL1900199 WXSH0024 WXSH0024 Active ingredient Chemical Drugs(1) New Drug Application 2019-06-24 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd In Review 2019-06-21 view
CXHL1900200 WXSH0024胶囊 WXSH0024 Capsule Chemical Drugs(1) New Drug Application 2019-06-24 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd In Review 2019-06-21 view
CXHL1900201 WXSH0024胶囊 WXSH0024 Capsule Chemical Drugs(1) New Drug Application 2019-06-24 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd In Review 2019-06-21 view
CXHL2101732 BC0306胶囊 BC-0306 Capsule Chemical Drugs(1) New Drug Application 2021-12-10 Shandong Danhong Pharmaceutical Co Ltd view
CXHL2101733 BC0306胶囊 BC-0306 Capsule Chemical Drugs(1) New Drug Application 2021-12-10 Shandong Danhong Pharmaceutical Co Ltd view
CXHL2101748 BC0305胶囊 BC-0305 Capsule Chemical Drugs(1) New Drug Application 2021-12-16 Shandong Danhong Pharmaceutical Co Ltd view
CXHL2101749 BC0305胶囊 BC-0305 Capsule Chemical Drugs(1) New Drug Application 2021-12-16 Shandong Danhong Pharmaceutical Co Ltd view
CXSL1800048 重组抗肿瘤坏死因子-α(TNF-α)全人源单克隆抗体注射液 adalimumab Injection Biological Products(2) New Drug Application 2018-04-28 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2018-10-08 view
CXSL1900064 注射用重组人脑利钠肽 recombinant human brain natriuretic peptide Lyophilized Biological Products(10) New Drug Application 2019-07-05 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd In Review 2019-07-04 view
CYHS2000215 注射用帕瑞昔布钠 parecoxib sodium Lyophilized Chemical Drugs(4) Generic Drug 2020-03-28 山东康爱制药有限公司,山东丹红制药有限公司 Beijing Zhengbang Pharmaceutical Co Ltd;Shandong Danhong Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2021-11-19 view
CYHS2000216 注射用帕瑞昔布钠 parecoxib sodium Lyophilized Chemical Drugs(4) Generic Drug 2020-03-28 山东康爱制药有限公司,山东丹红制药有限公司 Beijing Zhengbang Pharmaceutical Co Ltd;Shandong Danhong Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2021-11-19 view
CYHS2100240 注射用奥美拉唑钠(静脉滴注) Omeprazole Sodium Lyophilized Chemical Drugs(4) Generic Drug 2021-03-04 山东丹红制药有限公司 Shandong Danhong Pharmaceutical Co Ltd;Beijing Zhengbang Pharmaceutical Co Ltd In Review 2021-03-03 view
CYZB0801013 丹红注射液 Injection Chinese Herbal Medicine Supplementary Application 2008-06-16 菏泽步长制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2009-04-03 view
CYZB0908564 丹红注射液 Injection Chinese Herbal Medicine Supplementary Application 2009-11-30 菏泽步长制药有限公司 Shandong Danhong Pharmaceutical Co Ltd Certificate Issued 2010-04-27 view