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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
CXHB0700737 复方碳酸钙泡腾颗粒 Calcium carbonate;VITAMIN D Granule Chemical Drugs Supplementary Application 2007-11-08 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 2008-06-04 view
CXHB0900345 复方碳酸钙泡腾颗粒 Calcium carbonate;VITAMIN D Granule Chemical Drugs Supplementary Application 2009-07-08 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 2009-12-07 view
CXHB0900820 酒石酸罗格列酮 Rosiglitazone Tartrate Active ingredient Chemical Drugs Supplementary Application 2010-04-23 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 2012-09-25 view
CXHL1000142 右旋糖酐铁滴剂 iron dextran Drops Chemical Drugs(5) New Drug Application 2010-06-25 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
CXHL1000143 右旋糖酐铁颗粒 iron dextran Granule Chemical Drugs(5) New Drug Application 2010-06-25 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
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
CXHL1400019 地氯雷他定口服溶液 desloratadine Oral solution Chemical Drugs(5) New Drug Application 2014-10-09 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 2016-10-11 view
CXHL1501552 替比培南酯 Tebipenam pivoxil Active ingredient Chemical Drugs(3.1) New Drug Application 2015-10-26 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 2016-10-24 view
CXHL1501553 替比培南酯颗粒 Tebipenam pivoxil Granule Chemical Drugs(3.1) New Drug Application 2015-10-28 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 2016-10-24 view
CXHL2101468 制霉菌素凝胶 nystatin Gel Chemical Drugs(2.2) New Drug Application 2021-09-13 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CXHL2101604 注射用盐酸石蒜碱硫酯 Lyophilized Chemical Drugs(1) New Drug Application 2021-10-26 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CXHL2300146 西甲硅油口溶膜 simeticone Film Chemical Drugs(2.2) New Drug Application 2023-02-01 Shandong Dyne Marine Organism Pharmaceutical Co Ltd 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
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
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