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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL99476 氯苄律定 Active ingredient Chemical Drugs New Drug Application 2000-01-01 中国药科大学,山东新华制药股份有限公司 In Review view
CXL99477 氯苄律定片 Tablet Chemical Drugs New Drug Application 2000-01-01 中国药科大学,山东新华制药股份有限公司 In Review view
CXL00544 阿司匹林维生素C泡腾片 ascorbic acid;aspirin Tablet Chemical Drugs(4) New Drug Application 2000-09-30 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2002-03-19 view
CXL00545 阿司匹林维生素C泡腾片 ascorbic acid;aspirin Tablet Chemical Drugs(4) New Drug Application 2000-09-30 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Pending Approval 2002-03-01 view
CXS00744 阿司匹林肠溶缓释片 Aspirin Tablet, extended release Chemical Drugs(4) New Drug Application 2001-01-12 中国医药研究开发中心山东新华制药股份有限公司 Certificate Issued 2003-05-26 view
CXL00407 尼索地平缓释胶囊 nisoldipine Capsules, extended release Chemical Drugs(4) New Drug Application 2001-01-18 山东新华制药股份有限公司,中国药科大学 Certificate Issued 2001-09-10 view
CXL01217 单硝酸异山梨酯阿司匹林缓片 Aspirin;isosorbide mononitrate Tablet, extended release Chemical Drugs(4) New Drug Application 2001-04-23 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Approval Completed-Pending Certificated 2003-03-20 view
CXL01430 盐酸环丙沙星氢化可的松滴耳剂 ciprofloxacin hydrochloride;hydrocortisone Ear drops Chemical Drugs(4) New Drug Application 2001-06-05 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2002-01-21 view
CXL01428 替米哌隆注射液 timiperone Injection Chemical Drugs(2) New Drug Application 2001-06-05 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Approval Completed-Pending Certificated 2003-03-14 view
CXL01525 依诺沙星凝胶 enoxacin Gel Chemical Drugs(4) New Drug Application 2001-07-27 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2003-04-18 view
CXL00541 丙戊茶碱片 propentofylline Tablet Chemical Drugs(2) New Drug Application 2001-08-10 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2004-10-10 view
CXL00540 丙戊茶碱 propentofylline Active ingredient Chemical Drugs(2) New Drug Application 2001-08-10 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2004-10-10 view
CXS01437 格列美脲 glimepiride Active ingredient Chemical Drugs(2) New Drug Application 2001-09-03 美国杰西企业有限公司 山东新华制药股份有限公司 Certificate Issued 2001-10-17 view
CXL01737 复方异丙安替比林片 chlorzoxazone;propyphenazone Tablet Chemical Drugs(4) New Drug Application 2001-09-03 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Approval Completed-Pending Certificated 2003-02-24 view
CXS01438 格列美脲片 glimepiride Tablet Chemical Drugs(2) New Drug Application 2001-09-07 美国杰西企业有限公司 山东新华制药股份有限公司 Certificate Issued 2001-10-17 view
CXL01747 雷贝拉唑钠肠溶片 rabeprazole sodium Tablet Chemical Drugs(2) New Drug Application 2001-09-18 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Approval Completed-Pending Certificated 2003-04-03 view
CXL01746 雷贝拉唑钠 rabeprazole sodium Active ingredient Chemical Drugs(2) New Drug Application 2001-09-18 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Approval Completed-Pending Certificated 2003-04-03 view
CXL01837 苦参素注射液 marine Injection Chemical Drugs(4) New Drug Application 2001-09-26 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Approval Completed-Pending Certificated 2003-04-04 view
CXS01662 阿司匹林可待因片 aspirin;codeine phosphate Tablet Chemical Drugs(3) New Drug Application 2001-12-07 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2002-11-01 view
CXS20020072 胞磷胆碱氯化钠注射液 citicoline Injection Chemical Drugs(4) New Drug Application 2002-02-26 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2003-05-30 view