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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1402201 非诺贝酸胆碱缓释片 Tablet, extended release Chemical Drugs(3.1) New Drug Application 2015-05-07 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
CXHL1402200 非诺贝酸胆碱 Active ingredient Chemical Drugs(3.1) New Drug Application 2015-05-07 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-08-04 view
CXHL1501391 雷美替胺片 ramelteon Tablet Chemical Drugs(3.1) New Drug Application 2015-08-31 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-08-23 view
CXHL1501390 雷美替胺 ramelteon Active ingredient Chemical Drugs(3.1) New Drug Application 2015-08-31 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-08-23 view
CXHL1501372 福司氟康唑注射液 Fosfluconazole Injection Chemical Drugs(3.1) New Drug Application 2015-10-15 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-12-08 view
CXHL1501383 福司氟康唑 Fosfluconazole Active ingredient Chemical Drugs(3.1) New Drug Application 2015-10-15 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-12-08 view
CXHL1501384 泮托拉唑镁肠溶片 pantoprazole magnesium Tablet Chemical Drugs(3.1) New Drug Application 2015-09-23 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-09-03 view
CXHL1501389 泮托拉唑镁 pantoprazole magnesium Active ingredient Chemical Drugs(3.1) New Drug Application 2015-09-23 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-09-03 view
CXHL1501371 注射用福司氟康唑 Fosfluconazole Lyophilized Chemical Drugs(3.1) New Drug Application 2015-10-15 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-12-08 view
CYHB2008007 注射用磷酸左奥硝唑酯二钠 levornidazole disodium phosphate Lyophilized Chemical Drugs(原1.1) Supplementary Application 2020-10-22 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd In Review 2020-10-21 view
CXHL1402199 注射用左亚叶酸钠 sodium levofolinate Lyophilized Chemical Drugs(3.1) New Drug Application 2015-04-15 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-08-23 view
CXHL1401531 注射用HCP002 Lyophilized Chemical Drugs(1.1) New Drug Application 2014-12-17 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-03-01 view
CXHL1402198 左亚叶酸 levomefolate Active ingredient Chemical Drugs(3.1) New Drug Application 2015-04-15 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-08-23 view
CXHL1401530 HCP002 HCP-002 Other Chemical Drugs(1.1) New Drug Application 2014-12-17 陕西合成药业股份有限公司 Shaanxi Synthetic Pharmaceutical Co Ltd Certificate Issued 2016-03-01 view