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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
A20000148 西罗莫司 sirolimus Active ingredient Chemical Drugs Import Drug Application 2000-10-25 苏州立达制药有限公司 Wyeth Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-09-10 view
CXHB0601335 西罗莫司胶囊 sirolimus Capsule Chemical Drugs Supplementary Application 2006-09-14 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2007-04-25 view
CXHB0700058 西罗莫司口服溶液 sirolimus Oral solution Chemical Drugs Supplementary Application 2007-03-27 杭州中美华东制药有限公司 Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd Certificate Issued 2007-10-18 view
CXHB1400007 西罗莫司 sirolimus Active ingredient Chemical Drugs Supplementary Application 2014-03-11 福建科瑞药业有限公司 Fujian Kerui Pharmaceutical Co Ltd Certificate Issued 2014-11-21 view
CXHB2400021 西罗莫司滴眼液 sirolimus Eye drops Chemical Drugs(2.2) Supplementary Application 2024-01-30 Guangzhou Huachen Kangjie Pharmaceutical Co Ltd view
CXHB2400022 西罗莫司滴眼液 sirolimus Eye drops Chemical Drugs(2.2) Supplementary Application 2024-01-30 Guangzhou Huachen Kangjie Pharmaceutical Co Ltd view
CXHB2400023 西罗莫司滴眼液 sirolimus Eye drops Chemical Drugs(2.2) Supplementary Application 2024-01-30 Guangzhou Huachen Kangjie Pharmaceutical Co Ltd view
CXHL0501584 西罗莫司胶囊 sirolimus Capsule Chemical Drugs(5) New Drug Application 2005-10-16 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2006-07-04 view
CXHL0501585 西罗莫司胶囊 sirolimus Capsule Chemical Drugs(5) New Drug Application 2005-10-16 华北制药集团新药研究开发有限责任公司 North China Pharmaceutical Group New Drug R&D Co Ltd Certificate Issued 2006-07-04 view
CXHL0501610 西罗莫司片 sirolimus Tablet Chemical Drugs(5) New Drug Application 2005-09-28 杭州中美华东制药有限公司 Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd Certificate Issued 2006-07-04 view
CXHL0502102 西罗莫司片 sirolimus Tablet Chemical Drugs(5) New Drug Application 2005-12-12 浙江医药股份有限公司新昌制药厂 Zhejiang Medicine Co Ltd Certificate Issued 2007-10-18 view
CXHL0502592 西罗莫司胶囊 sirolimus Capsule Chemical Drugs(5) New Drug Application 2006-03-08 杭州中美华东制药有限公司 Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd Certificate Issued 2007-10-18 view
CXHL0700018 西罗莫司分散片 sirolimus Tablet Chemical Drugs(5) New Drug Application 2007-03-14 江苏信孚药业有限公司 Wuxi STA Pharmaceutical Co Ltd Certificate Issued 2009-02-12 view
CXHL0700311 西罗莫司胶囊 sirolimus Capsule Chemical Drugs(5) New Drug Application 2008-04-14 天津和治药业有限公司 Tianjin Hezhi Pharmaceutical Group Co Ltd Certificate Issued 2010-06-08 view
CXHL0700312 西罗莫司胶囊 sirolimus Capsule Chemical Drugs(5) New Drug Application 2007-11-23 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2009-08-20 view
CXHL1301276 替西罗莫司 temsirolimus Active ingredient Chemical Drugs(3.1) New Drug Application 2014-03-08 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2016-02-04 view
CXHL1301277 注射用替西罗莫司 temsirolimus Lyophilized Chemical Drugs(3.1) New Drug Application 2014-03-08 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2016-02-04 view
CXHL2101013 注射用西罗莫司(白蛋白结合型) sirolimus Lyophilized Chemical Drugs(2.2) New Drug Application 2021-03-27 CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co Ltd view
CXHL2101092 西罗莫司滴眼液 sirolimus Eye drops Chemical Drugs(2.2) New Drug Application 2021-04-28 Fuzhou Haoji Medical Technology Development Co Ltd view
CXHL2101465 西罗莫司滴眼液 sirolimus Eye drops Chemical Drugs(2.2) New Drug Application 2021-09-13 Fuzhou Haoji Medical Technology Development Co Ltd view