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 |