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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS01346 格列美脲 glimepiride Active ingredient Chemical Drugs(2) New Drug Application 2001-07-23 成都市高新区药工医药生物技术研究所山东达因海洋生物制药股份有限公司 Certificate Issued 2001-09-27 view
CXS01347 格列美脲片 glimepiride Tablet Chemical Drugs(2) New Drug Application 2001-07-23 成都市高新区药工医药生物技术研究所山东达因海洋生物制药股份有限公司 Certificate Issued 2001-09-27 view
CXb20020408 格列美脲 glimepiride Active ingredient Chemical Drugs(2) Supplementary Application 2002-07-01 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2003-01-23 view
CXb20020409 格列美脲片 glimepiride Tablet Chemical Drugs(2) Supplementary Application 2002-07-01 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2003-01-22 view
BFX20020360 罗红霉素胶囊 roxithromycin Capsule Chemical Drugs Generic Drug 2002-08-23 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-12-03 view
BFX20020361 罗红霉素胶囊 roxithromycin Capsule Chemical Drugs Generic Drug 2002-08-23 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-12-03 view
X0301583 复方碳酸钙泡腾颗粒 Calcium carbonate;VITAMIN D Granule Chemical Drugs(5) New Drug Application 2003-12-28 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2004-07-12 view
X0301584 复方碳酸钙泡腾颗粒 Calcium carbonate;VITAMIN D Granule Chemical Drugs(5) New Drug Application 2003-12-28 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2004-07-12 view
X0404480 瑞舒伐他汀钙片 rosuvastatin calcium Tablet Chemical Drugs(3.1) New Drug Application 2004-08-12 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-04-11 view
X0404479 瑞舒伐他汀钙片 rosuvastatin calcium Tablet Chemical Drugs(3.1) New Drug Application 2004-08-12 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-04-11 view
X0404478 瑞舒伐他汀钙 rosuvastatin calcium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-08-12 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-04-18 view
X0303858 复方缬沙坦胶囊 hydrochlorothiazide;valsartan Capsule Chemical Drugs(3.2) New Drug Application 2004-08-17 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2004-12-15 view
Y0410079 二巯丁二酸 succimer Active ingredient Chemical Drugs(6) Generic Drug 2004-09-09 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-02-04 view
Y0410081 二巯丁二酸胶囊 succimer Capsule Chemical Drugs(6) Retrial 2004-09-09 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-02-04 view
Y0410080 二巯丁二酸胶囊 succimer Capsule Chemical Drugs(6) Generic Drug 2004-09-09 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-02-04 view
X0402119 依帕司他片 epalrestat Tablet Chemical Drugs New Drug Application 2004-12-09 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-05-27 view
X0402118 依帕司他 epalrestat Active ingredient Chemical Drugs New Drug Application 2004-12-09 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-05-27 view
CYHS0502080 阿奇霉素颗粒 azithromycin Granule Chemical Drugs(6) Generic Drug 2005-04-13 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2005-09-07 view
CXHS0600049 酒石酸罗格列酮片 Rosiglitazone Tartrate Tablet Chemical Drugs(4) New Drug Application 2006-03-24 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2008-06-27 view
CXHS0600048 酒石酸罗格列酮 Rosiglitazone Tartrate Active ingredient Chemical Drugs(4) New Drug Application 2006-03-24 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2008-05-09 view