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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0300559 注射用甲磺酸帕珠沙星 pazufloxacin mesylate Lyophilized Chemical Drugs(3.1) New Drug Application 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-10-17 view
X0300558 甲磺酸帕珠沙星氯化钠注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-02-09 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-10-17 view
X0300557 甲磺酸帕珠沙星注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-02-09 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-10-17 view
X0300556 甲磺酸帕珠沙星 pazufloxacin mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2003-02-09 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-10-17 view
X0300552 阿德福韦酯胶囊 adefovir dipivoxil Capsule Chemical Drugs(3.1) New Drug Application 2003-02-09 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-09-19 view
X0300551 阿德福韦酯片 adefovir dipivoxil Tablet Chemical Drugs(3.1) New Drug Application 2003-02-09 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-09-19 view
X0300550 阿德福韦酯 adefovir dipivoxil Active ingredient Chemical Drugs(3.1) New Drug Application 2003-02-09 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-09-19 view
CXS20020921 藻酸双酯钠氯化钠注射液 Alginidatum Natricum Injection Chemical Drugs(4) New Drug Application 2002-09-25 山西舒尔药业有限责任公司 山西恒源制药有限公司 Certificate Issued 2003-12-30 view
CXS20020920 苦参碱氯化钠注射液 Matrine Injection Chemical Drugs(4) New Drug Application 2002-09-25 山西舒尔药业有限责任公司 山西恒源制药有限公司 Certificate Issued 2004-03-05 view
CXS20020767 西沙必利胶囊 cisapride Capsule Chemical Drugs(4) New Drug Application 2003-08-30 山西省医药规划设计院(有限公司)山西舒尔药业有限责任公司 太原市福兰德制药有限公司 Certificate Issued 2005-03-25 view
CXS20020766 西沙必利片 cisapride Tablet Chemical Drugs(4) New Drug Application 2003-08-30 山西舒尔药业有限责任公司 山西省太原晋阳制药厂 Certificate Issued 2004-05-21 view
CXS20020765 西沙必利 cisapride Active ingredient Chemical Drugs(4) New Drug Application 2003-08-30 山西舒尔药业有限责任公司 山西省太原晋阳制药厂 Certificate Issued 2004-05-21 view
CXS20020632 阿奇霉素葡萄糖注射液 azithromycin Injection Chemical Drugs(4) New Drug Application 2004-02-13 北京博尔达生物技术开发有限公司山西舒尔药业有限责任公司 重庆莱美药业有限公司 In Review 2002-08-01 view
CXL20022423 5%氨来呫诺糊剂 amlexanox Paste Chemical Drugs(2) New Drug Application 2002-09-16 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-05-16 view
CXL20022422 氨来呫诺 amlexanox Active ingredient Chemical Drugs(2) New Drug Application 2002-09-16 山西舒尔药业有限责任公司 Shanxi Shuer Pharmaceutical Co Ltd Certificate Issued 2003-05-16 view