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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2000271 注射用重组抗IgE单克隆抗体 omalizumab Lyophilized Biological Products(3.3) New Drug Application 2020-09-22 石药集团百克(山东)生物制药股份有限公司 CSPC Baike(shandong)Bio-Pharmaceutical Co Ltd In Review 2020-09-21 view
CXSL2000091 注射用重组抗IgE单克隆抗体 omalizumab Lyophilized Biological Products(2) New Drug Application 2020-05-06 石药集团百克(山东)生物制药股份有限公司 CSPC Baike(shandong)Bio-Pharmaceutical Co Ltd In Review 2020-05-01 view
CXSL1400132 注射用重组抗IgE单克隆抗体 omalizumab Lyophilized Biological Products(2) New Drug Application 2015-02-26 深圳龙瑞药业有限公司 Lonn Ryonn PHARMA Ltd Certificate Issued 2016-09-26 view