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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
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
CYHS2402894 盐酸可乐定缓释片 Clonidine Hydrochloride Tablet, extended release Chemical Drugs(3) Generic Drug 2024-09-04 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHS2401339 盐酸氟西汀分散片 fluoxetine hydrochloride Tablet Chemical Drugs(4) Generic Drug 2024-05-08 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHS2400465 丙戊酸钠口服溶液 sodium valproate Oral solution Chemical Drugs(4) Generic Drug 2024-02-03 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHS2300127 西甲硅油乳剂 simeticone Oral emulsion Chemical Drugs(4) Generic Drug 2023-01-13 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHS2200662 盐酸托莫西汀胶囊 atomoxetine hydrochloride Capsule Chemical Drugs(4) Generic Drug 2022-04-26 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHS2100013 盐酸托莫西汀口服溶液 atomoxetine hydrochloride Oral solution Chemical Drugs(4) Generic Drug 2021-01-06 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 2021-01-06 view
CYHS2000931 盐酸可乐定缓释片 Clonidine Hydrochloride Tablet, extended release Chemical Drugs(3) Generic Drug 2020-12-28 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 2021-09-02 view
CYHS1900805 地氯雷他定口服溶液 desloratadine Oral solution Chemical Drugs(3) Generic Drug 2019-12-05 山东达因海洋生物制药股份有限公司 Shandong Dyne Marine Organism Pharmaceutical Co Ltd In Review 2019-12-04 view
CYHS1700460 口服补液盐散(Ⅲ) Powder Chemical Drugs(4) Generic Drug 2018-05-02 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 2019-08-08 view