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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2200431 SH-1028片 Oritinib mesylate Tablet Chemical Drugs(1) New Drug Application 2022-06-28 Nanjing Sanhome Pharmaceutical CoLtd view
CXHL1700131 SH-1028片 Oritinib mesylate Tablet Chemical Drugs(1) New Drug Application 2017-07-18 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2018-01-04 view
CXHL1700130 SH-1028片 Oritinib mesylate Tablet Chemical Drugs(1) New Drug Application 2017-07-18 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2018-01-04 view
CXHL1700129 SH-1028 Oritinib mesylate Active ingredient Chemical Drugs(1) New Drug Application 2017-07-18 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2018-01-04 view
CXHB1900021 SH-1028片 Oritinib mesylate Tablet Chemical Drugs Supplementary Application 2019-04-12 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2019-06-12 view
CXHB1900020 SH-1028片 Oritinib mesylate Tablet Chemical Drugs Supplementary Application 2019-04-12 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd Certificate Issued 2019-06-12 view
CXHB1900019 SH-1028 Oritinib mesylate Active ingredient Chemical Drugs Supplementary Application 2019-04-12 南京圣和药业股份有限公司 Nanjing Sanhome Pharmaceutical CoLtd In Review 2019-04-11 view