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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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