Acceptance No. | Drug Name | Active Ingredient | Dosage Form | Classification | Submission | Acceptance Date | Manufacturers | Manufacturers | Review Status | Status Date | View |
---|---|---|---|---|---|---|---|---|---|---|---|
CXHL1900018 | PB-201片 | PB-201 | Tablet | Chemical Drugs(1) | New Drug Application | 2019-01-14 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | In Review | 2019-01-11 | view |
CXHL1200115 | 聚乙二醇化艾塞那肽注射液 | PB-119 | Injection | Chemical Drugs(1.1) | New Drug Application | 2012-04-28 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | Certificate Issued | 2013-09-13 | view |
CXHB1700048 | 聚乙二醇化艾塞那肽 | PEGylated exenatide | Active ingredient | Chemical Drugs | Supplementary Application | 2017-06-08 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | Certificate Issued | 2017-10-17 | view |
CXHB2000061 | 聚乙二醇化艾塞那肽注射液 | PB-119 | Injection | Chemical Drugs | Supplementary Application | 2020-06-29 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | In Review | 2020-06-28 | view |
CXHB1700049 | 聚乙二醇化艾塞那肽注射液 | PB-119 | Injection | Chemical Drugs | Supplementary Application | 2017-06-08 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | Certificate Issued | 2017-10-17 | view |
CXHL1900017 | PB-201 | PB-201 | Active ingredient | Chemical Drugs(1) | New Drug Application | 2019-01-14 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | In Review | 2019-01-11 | view |
CXHL1900019 | PB-201片 | PB-201 | Tablet | Chemical Drugs(1) | New Drug Application | 2019-01-14 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | In Review | 2019-01-11 | view |
CXHL1200114 | 聚乙二醇化艾塞那肽 | PEGylated exenatide | Active ingredient | Chemical Drugs(1.1) | New Drug Application | 2012-04-28 | 派格生物医药(苏州)有限公司 | Peg BIO Co Ltd | Certificate Issued | 2013-09-13 | view |