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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1600316 LXI-15028片 tegoprazan Tablet Chemical Drugs(1) New Drug Application 2016-12-30 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2017-07-06 view
CXHL1600315 LXI-15028 tegoprazan Active ingredient Chemical Drugs(1) New Drug Application 2016-12-30 山东罗欣药业集团恒欣药业有限公司 Shandong Luoxin Pharmaceutical Group HENGXIN Pharmaceutical Co Ltd Certificate Issued 2017-07-06 view
CXHL1600317 LXI-15028片 tegoprazan Tablet Chemical Drugs(1) New Drug Application 2016-12-30 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2017-07-06 view
CXHS2000047 替戈拉生片 tegoprazan Tablet Chemical Drugs(1) New Drug Application 2021-01-14 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd In Review 2022-01-19 view
CXHB2101005 LXI-15028片 tegoprazan Tablet Chemical Drugs(2.4) Supplementary Application 2021-04-19 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd view
CXHL2101815 替戈拉生片 tegoprazan Tablet Chemical Drugs(2.4) New Drug Application 2021-12-30 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd view
CXHS2300034 替戈拉生片 tegoprazan Tablet Chemical Drugs(2.4) New Drug Application 2023-02-20 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd view
CXHS2300114 替戈拉生片 tegoprazan Tablet Chemical Drugs(2.4) New Drug Application 2023-12-14 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd view