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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
CXHL2100209 聚乙二醇化艾塞那肽注射液 PB-119 Injection Chemical Drugs(1) New Drug Application 2021-03-27 派格生物医药(苏州)股份有限公司 Peg BIO Co Ltd In Review 2021-03-26 view
CXHL2101223 聚乙二醇化艾塞那肽注射液 PB-119 Injection Chemical Drugs(1) New Drug Application 2021-06-25 Peg BIO Co Ltd view
CXHS2300088 维派那肽注射液 PB-119 Injection Chemical Drugs(1) New Drug Application 2023-09-26 view
CXHB2400043 聚乙二醇化艾塞那肽注射液 PB-119 Injection Chemical Drugs(1) Supplementary Application 2024-02-19 Peg BIO Co Ltd view