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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
A20010003 奥美拉唑肠溶胶囊 omeprazole Capsule Chemical Drugs New Drug Application 2003-11-28 北京韩美药品有限公司 Beijing Hanmi Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
A20010004 奥美拉唑肠溶颗粒 omeprazole Granule Chemical Drugs New Drug Application 2003-11-28 北京韩美药品有限公司 Beijing Hanmi Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
A20010008 奥美拉唑钠 Omeprazole Sodium Active ingredient Chemical Drugs New Drug Application 2001-04-27 阿斯特拉(无锡)制药有限公司 Astrazeneca Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-09-12 view
A20010010 埃索美拉唑镁包衣微丸 esomeprazole magnesium Pellet Chemical Drugs New Drug Application 2001-04-27 阿斯特拉(无锡)制药有限公司 Astrazeneca Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-08-15 view
A20020068 奥美拉唑 omeprazole Active ingredient Chemical Drugs New Drug Application 2003-11-10 韩国凯特伟商社北京代表处 Approval Completed-Pending Certificated view
A20020069 奥美拉唑 omeprazole Active ingredient Chemical Drugs New Drug Application 2004-06-03 韩国凯特伟商社北京代表处 Approval Completed-Pending Certificated view
A20020126 奥美拉唑缓释微丸 omeprazole Pellet Chemical Drugs New Drug Application 2002-10-15 北京德众万全药物技术开发有限公司 Beijing Dezhong Wanquan Pharmaceutical Technology Development Co Ltd Approval Completed-Pending Certificated 2003-03-13 view
BFX20010054 奥美拉唑肠溶胶囊 omeprazole Capsule Chemical Drugs Generic Drug 2001-04-09 山东淄博万杰实业股份有限公司制药厂 Pharmaceutical Factory of Shandong Wanjie Hi Tech Co Ltd In Approval view
BFX20010147 奥美拉唑肠溶胶囊 omeprazole Capsule Chemical Drugs Generic Drug 2001-07-16 常州四药制药有限公司 Changzhou Siyao Pharmaceuticals Co Ltd Approval Completed-Pending Certificated view
CBHR0800001 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs State Standards 2008-04-23 长春富春制药有限公司 Changchun HaiYue Pharmaceutical Limited By Share Ltd Certificate Issued 2009-05-05 view
CBHR0800017 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs State Standards 2008-09-23 海南中化联合制药工业有限公司 Double-Crane Pharmaceutical(Hainan) Co Ltd Certificate Issued 2009-05-05 view
CBHR0800018 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs State Standards 2008-09-23 海南中化联合制药工业有限公司 Double-Crane Pharmaceutical(Hainan) Co Ltd Certificate Issued 2009-06-11 view
CBHR0900056 奥美拉唑肠溶胶囊 omeprazole Capsule Chemical Drugs State Standards 2009-09-04 浙江亚太药业股份有限公司 Zhejiang Yatai Pharmaceutical Co Ltd Certificate Issued 2010-02-26 view
CXb01273 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs(4) Supplementary Application 2001-07-10 江苏吴中实业股份有限公司苏州第六制药厂 Suzhou Pharmaceutical Factory Certificate Issued 2002-04-10 view
CXb20020061 奥美拉唑肠溶片 omeprazole Tablet Chemical Drugs(4) Supplementary Application 2002-01-31 青岛双鲸药业有限公司 Qingdao Double Whale Pharmaceutical Co Ltd Certificate Issued 2002-09-23 view
CXb20020452 奥美拉唑肠溶片 omeprazole Tablet Chemical Drugs(4) Supplementary Application 2002-07-22 青岛双鲸药业有限公司 Qingdao Double Whale Pharmaceutical Co Ltd Certificate Issued 2003-02-19 view
CXHB0501058 奥美拉唑 omeprazole Active ingredient Chemical Drugs Supplementary Application 2005-07-10 汕头经济特区?滨制药厂 Shantou Special Economic Zone Tuobin Pharmaceutical Factory Certificate Issued 2005-11-17 view
CXHB0800178 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs Supplementary Application 2008-06-10 阿斯利康制药有限公司 Astrazeneca Pharmaceutical Co Ltd Certificate Issued 2009-06-25 view
CXHB0800179 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs Supplementary Application 2008-06-10 阿斯利康制药有限公司 Astrazeneca Pharmaceutical Co Ltd Certificate Issued 2009-06-25 view
CXHB0800507 奥美拉唑镁 omeprazole magnesium Active ingredient Chemical Drugs Supplementary Application 2009-04-10 许昌奥森制药有限公司 Xuchang High Tech Pharmaceutical Co Ltd Certificate Issued 2009-10-21 view