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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 Shandong Dyne Marine Organism Pharmaceutical Co Ltd 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 Shandong Dyne Marine Organism Pharmaceutical Co Ltd Certificate Issued 2001-09-27 view
CYHB1704425 复方碳酸钙泡腾颗粒 calcium carbonate;vitamin d Granule Chemical Drugs Supplementary Application 2018-01-02 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 2018-04-10 view
CYHS1000272 氨溴特罗口服溶液 ambroxol hydrochloride;clenbuterol Oral solution Chemical Drugs(6) Generic Drug 2010-07-29 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 2011-12-13 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;Chifeng Boda Pharmaceutical Research Institute Certificate Issued 2008-06-27 view
CYHS1200706 蒙脱石散 diosmectite Powder Chemical Drugs(6) Generic Drug 2012-12-05 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 2019-01-17 view
CXHS0800136 瑞舒伐他汀钙 rosuvastatin calcium Active ingredient Chemical Drugs(3.1) New Drug Application 2008-11-19 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 2015-10-13 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;Sichuan University Certificate Completed-Pending Issued 2004-07-12 view
CYHS1500271 碳酸钙D3咀嚼片(Ⅱ) calcium carbonate;colecalciferol Tablet Chemical Drugs(6) Generic Drug 2015-08-07 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 2017-09-05 view
CYHS0900584 利福昔明干混悬剂 rifaximin Suspension Chemical Drugs(6) Generic Drug 2009-11-02 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 2011-11-22 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;Shenyang Huatai Medication Research Co Ltd;Shenzhen Neptunus Pharmaceutical Co Ltd Certificate Issued 2005-05-27 view
CYHB2009783 维生素D滴剂 vitamin d Drops Chemical Drugs(原6) Supplementary Application 2020-11-28 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd In Review 2021-03-02 view
CYHS1101345 葡萄糖酸锌颗粒 Zinc gluconate Granule Chemical Drugs(6) Generic Drug 2012-03-23 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 2017-01-19 view
CXHB0601953 缬沙坦氢氯噻嗪胶囊 hydrochlorothiazide;valsartan Capsule Chemical Drugs Supplementary Application 2007-01-26 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 2007-07-11 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
CYHS0900025 布洛芬混悬液 ibuprofen Suspension Chemical Drugs(6) Generic Drug 2009-03-27 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 2010-08-20 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
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;Chifeng Boda Pharmaceutical Research Institute Certificate Issued 2008-05-09 view
CXHL1200323 低渗口服补液盐散 Powder Chemical Drugs(3.2) New Drug Application 2012-08-13 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 2014-11-21 view
CXHS0800138 瑞舒伐他汀钙片 rosuvastatin calcium Tablet Chemical Drugs(3.1) New Drug Application 2008-11-19 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 2015-10-13 view