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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1501312 HMPL-523乙酸盐 sovleplenib acetate Active ingredient Chemical Drugs(1.1) New Drug Application 2015-07-17 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2016-05-31 view
CXHL1500771 HMPL-523乙酸盐 sovleplenib acetate Active ingredient Chemical Drugs(1.1) New Drug Application 2015-07-17 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2016-11-23 view
CXHL1501313 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs(1.1) New Drug Application 2015-07-17 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2016-05-19 view
CXHB1800098 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-12-26 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd In Review 2018-12-25 view
CXHL1500772 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs(1.1) New Drug Application 2015-07-17 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2016-11-23 view
CYHB1802442 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-05-11 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2018-07-06 view
CXHB1800097 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-12-26 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd In Review 2018-12-25 view
CYHB1802440 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-05-11 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2018-07-06 view
CXHB1800096 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-12-25 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd In Review 2018-12-24 view
CYHB1802439 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-05-11 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2018-07-06 view
CXHL2200268 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs(1) New Drug Application 2022-05-07 Hutchison MediPharma Co Ltd view
CXHL1501314 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs(1.1) New Drug Application 2015-07-17 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2016-05-19 view
CXHB1800099 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-12-26 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd In Review 2018-12-25 view
CXHL1500773 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs(1.1) New Drug Application 2015-07-17 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2016-11-23 view
CYHB1802438 HMPL-523乙酸盐片 sovleplenib acetate Tablet Chemical Drugs Supplementary Application 2018-05-11 和记黄埔医药(上海)有限公司 Hutchison MediPharma Co Ltd Certificate Issued 2018-07-06 view
CXHS2400004 醋酸索乐匹尼布片 sovleplenib acetate Tablet Chemical Drugs(1) New Drug Application 2024-01-11 view