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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1300982 泊沙康唑 posaconazole Active ingredient Chemical Drugs(3.1) New Drug Application 2013-12-19 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-01-22 view
CXHL1300983 泊沙康唑干混悬剂 posaconazole Suspension Chemical Drugs(5) New Drug Application 2013-12-19 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-01-22 view
CXHL1401294 美沙拉嗪控释胶囊 mesalazine Capsules, extended release Chemical Drugs(5) New Drug Application 2014-12-17 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-03-01 view
CXHL1401853 利伐沙班 rivaroxaban Active ingredient Chemical Drugs(3.1) New Drug Application 2015-05-22 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-03-01 view
CXHL1402086 甲磺酸达比加群酯 dabigatran etexilate mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2015-05-15 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CXHL1402087 甲磺酸达比加群酯胶囊 dabigatran etexilate mesylate Capsule Chemical Drugs(3.1) New Drug Application 2015-05-15 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CXHL1402088 甲磺酸达比加群酯胶囊 dabigatran etexilate mesylate Capsule Chemical Drugs(3.1) New Drug Application 2015-06-01 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CXHL1501374 氢溴酸沃替西汀 vortioxetine hydrobromide Active ingredient Chemical Drugs(3.1) New Drug Application 2015-09-23 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-09-04 view
CXHL1501375 氢溴酸沃替西汀片 vortioxetine hydrobromide Tablet Chemical Drugs(3.1) New Drug Application 2015-09-23 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-09-04 view
CXHL1501377 氢溴酸沃替西汀片 vortioxetine hydrobromide Tablet Chemical Drugs(3.1) New Drug Application 2015-09-25 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-09-04 view
CXHL1501827 新利司他 cetilistat Active ingredient Chemical Drugs(3.1) New Drug Application 2015-12-07 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-10-18 view
CXHL1501828 新利司他片 cetilistat Tablet Chemical Drugs(3.1) New Drug Application 2015-11-30 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-10-24 view
CYHS1100792 苯磺酸氨氯地平片 amlodipine besylate Tablet Chemical Drugs(6) Generic Drug 2011-12-23 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2015-09-23 view
CYHS1300400 格列齐特缓释片 gliclazide Tablet, extended release Chemical Drugs(6) Generic Drug 2013-08-14 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2015-12-24 view
CYHS1300871 对乙酰氨基酚缓释片 paracetamol Tablet, extended release Chemical Drugs(6) Generic Drug 2013-11-20 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2015-12-30 view
CYHS1300889 盐酸氨溴索缓释片 ambroxol hydrochloride Tablet, extended release Chemical Drugs(6) Generic Drug 2013-12-02 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-01-14 view
CYHS1301802 格列吡嗪缓释片 glipizide Tablet, extended release Chemical Drugs(6) Generic Drug 2014-04-17 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-01-22 view
CYHS1301803 盐酸维拉帕米缓释片 verapamil hydrochloride Tablet, extended release Chemical Drugs(6) Generic Drug 2014-04-11 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-01-29 view
CYHS1400997 甲硝唑缓释片 metronidazole Tablet, extended release Chemical Drugs(6) Generic Drug 2014-11-06 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-02-04 view
CYHS1401187 苯扎贝特缓释片 bezafibrate Tablet, extended release Chemical Drugs(6) Generic Drug 2015-02-03 陕西步长高新制药有限公司 Shaanxi Buchang Hi Tech Pharmaceutical Co Ltd Certificate Issued 2016-02-19 view