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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0305928 重组(毕赤酵母)人干扰素a1b滴眼液 Recombinant Human Interferon α1b Eye drops Biological Products(10) New Drug Application 2004-08-27 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2005-06-23 view
X0304353 盐酸二甲双胍缓释片 metformin hydrochloride Tablet, extended release Chemical Drugs(5) New Drug Application 2004-08-12 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2005-04-13 view
X0305929 重组(毕赤酵母)人干扰素a1b喷雾剂 Recombinant Human Interferon α1b Spray Biological Products(10) New Drug Application 2003-11-13 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2006-09-13 view
X0301018 噻康唑喷雾剂 tioconazole Spray Chemical Drugs(5) New Drug Application 2003-11-05 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2004-03-12 view
X0200105 复方盐酸西替利嗪/盐酸伪麻黄碱缓释片 cetirizine hydrochloride;pseudoephedrine hydrochloride Tablet, extended release Chemical Drugs(3.2) New Drug Application 2003-09-02 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2004-03-19 view
X0302617 雷贝拉唑钠肠溶片 rabeprazole sodium Tablet Chemical Drugs New Drug Application 2003-05-28 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2003-12-30 view
X0300238 复方法莫替丁咀嚼片 Calcium carbonate;famotidine;Magnesium hydroxide Tablet Chemical Drugs(3.2) New Drug Application 2003-01-21 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2003-08-18 view
FX20020664 奥美拉唑肠溶胶囊 omeprazole Capsule Chemical Drugs Generic Drug 2002-10-25 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-03-19 view
CXS20020583 依托度酸缓释片 etodolac Tablet, extended release Chemical Drugs(4) New Drug Application 2002-07-10 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2003-06-20 view
CXL20020438 盐酸左旋沙丁胺醇气雾剂 levosalbutamol hydrochloride Aerosol Chemical Drugs(4) New Drug Application 2002-03-18 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-03-24 view
BFX20020005 灰黄霉素片 griseofulvin Tablet Chemical Drugs Generic Drug 2002-02-23 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-07-25 view
BFX20020006 罗红霉素胶囊 roxithromycin Capsule Chemical Drugs Generic Drug 2002-02-23 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-07-03 view
CXS01768 复方福尔可定口服液 guaifenesin;pholcodine;PSEUDOEPHEDRINE HYDROCHLORIDE;Triprolidine hydrochloride;; Oral solution Chemical Drugs(4) New Drug Application 2002-01-21 上海信谊药业有限公司重庆信谊东方药业股份有限公司 Certificate Issued 2003-09-19 view
CXL01G23 盐酸二甲双胍缓释片 metformin hydrochloride Tablet, extended release Chemical Drugs(4) New Drug Application 2001-12-14 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2002-12-11 view
CXS01606 异福酰胺片 isoniazid;pyrazinamide;rifampicin Tablet Chemical Drugs(4) New Drug Application 2001-12-06 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Certificate Issued 2002-06-18 view
CXS01522 硝苯地平缓释片 nifedipine Tablet, extended release Chemical Drugs(4) New Drug Application 2001-10-24 华中科技大学同济医学院药学院上海信谊药业有限公司 Certificate Issued 2003-11-24 view
BFX20010182 二羟丙茶碱片 diprophylline Tablet Chemical Drugs Generic Drug 2001-09-28 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
BFX20010135 氯霉素片 chloramphenicol Tablet Chemical Drugs Generic Drug 2001-07-26 上海信谊药业有限公司 Shanghai Xinyi Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-01-21 view
CXS00702 复方磷酸可待因片 Caffeine;Codeine phosphate;diphenhydramine hydrochloride;paracetamol Tablet Chemical Drugs(4) New Drug Application 2000-12-07 上海信谊药业有限公司上海信谊百路达药业有限公司 Certificate Issued 2001-10-15 view