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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
CYHL2101012 水合氯醛栓 Chloral hydrate Suppository Chemical Drugs(3) Generic Drug 2021-05-26 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
CYHB2302462 蒙脱石散 diosmectite Powder Chemical Drugs(原6) Supplementary Application 2023-11-10 Shandong Dyne Marine Organism Pharmaceutical Co Ltd 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
CYHB2250515 依帕司他片 epalrestat Tablet Chemical Drugs Supplementary Application 2022-08-17 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHL2300075 异丙托溴铵吸入气雾剂 ipratropium bromide Aerosol Chemical Drugs(4) Generic Drug 2023-06-08 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
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
CYHL2300019 丙戊酸钠口服溶液 sodium valproate Oral solution Chemical Drugs(4) Generic Drug 2023-02-11 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHB2400461 地氯雷他定口服溶液 desloratadine Oral solution Chemical Drugs(3) Supplementary Application 2024-04-02 Shandong Dyne Marine Organism Pharmaceutical Co Ltd view
CYHL2101033 盐酸可乐定缓释片 Clonidine Hydrochloride Tablet, extended release Chemical Drugs(3) Generic Drug 2021-10-29 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
CYHB2400462 地氯雷他定口服溶液 desloratadine Oral solution Chemical Drugs(3) Supplementary Application 2024-04-02 Shandong Dyne Marine Organism Pharmaceutical Co Ltd 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
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