Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXSL2400547 | 重组全人源抗PCSK9单克隆抗体注射液 | Injection | Biological Products(1) | New Drug Application | 2024-08-17 | view | |||||
CXSB2300075 | 重组全人源抗PCSK9单克隆抗体注射液 | Injection | Biological Products(原1) | Supplementary Application | 2023-07-19 | view | |||||
CXSL1900102 | 重组全人源抗PCSK9单克隆抗体注射液 | Injection | Biological Products(1) | New Drug Application | 2019-09-10 | 信立泰(成都)生物技术有限公司 | Chengdu Jinkai Biotech Co Ltd | In Review | 2019-09-09 | view | |
CXSL2000019 | 重组全人源抗PCSK9单克隆抗体注射液 | Injection | Biological Products(1) | New Drug Application | 2020-02-14 | 天士力生物医药股份有限公司 | Shanghai Tasly Pharmaceutical Co Ltd | In Review | 2020-02-13 | view |