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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0305365 福多司坦胶囊 fudosteine Capsule Chemical Drugs(3.1) New Drug Application 2004-08-03 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-11-22 view
X0305364 福多司坦 fudosteine Active ingredient Chemical Drugs(3.1) New Drug Application 2004-08-03 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-11-19 view
X0400716 法罗培南钠 fropenem sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-02-18 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-08-27 view
X0400718 法罗培南钠片 fropenem sodium Tablet Chemical Drugs(3.1) New Drug Application 2004-02-18 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-08-27 view
X0400717 法罗培南钠片 fropenem sodium Tablet Chemical Drugs(3.1) New Drug Application 2004-02-18 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-08-27 view
CXL20022481 盐酸尼非卡兰 Nifekalant Hydrochloride Active ingredient Chemical Drugs(2) New Drug Application 2003-11-20 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-04-29 view
CXL20022482 注射用盐酸尼非卡兰 Nifekalant Hydrochloride Lyophilized Chemical Drugs(2) New Drug Application 2003-11-20 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-04-29 view
CXL20023015 注射用雷替曲塞 raltitrexed Lyophilized Chemical Drugs(2) New Drug Application 2003-10-16 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-03-12 view
CXL20023014 雷替曲塞 raltitrexed Active ingredient Chemical Drugs(2) New Drug Application 2003-10-16 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-03-12 view
X0301846 利福昔明干混悬剂 rifaximin Suspension Chemical Drugs(3.1) New Drug Application 2003-04-08 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2003-12-05 view
X0300209 米诺地尔喷雾剂 minoxidil Spray Chemical Drugs(5) New Drug Application 2003-01-21 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-02-23 view
CXL20022284G 注射用盐酸氨溴索 ambroxol hydrochloride Lyophilized Chemical Drugs(4) New Drug Application 2002-11-13 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2003-09-19 view
CXL20021734 利福昔明片 rifaximin Tablet Chemical Drugs(2) New Drug Application 2002-07-30 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2003-11-14 view
CXL20021733 利福昔明 rifaximin Active ingredient Chemical Drugs(2) New Drug Application 2002-07-30 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2003-11-14 view
CXL20021735 利福昔明胶囊 rifaximin Capsule Chemical Drugs(2) New Drug Application 2002-07-30 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2003-11-14 view
CXL20020966 依达拉奉注射液 edaravone Injection Chemical Drugs(2) New Drug Application 2002-05-20 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Approval Completed-Pending Certificated 2003-01-30 view
CXL20020965 依达拉奉 edaravone Active ingredient Chemical Drugs(2) New Drug Application 2002-05-20 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Approval Completed-Pending Certificated 2003-01-30 view
CXL20020967 依达拉奉氯化钠注射液 edaravone Injection Chemical Drugs(2) New Drug Application 2002-05-20 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Approval Completed-Pending Certificated 2003-01-30 view
CXL20020319 盐酸二甲双胍缓释片 metformin hydrochloride Tablet, extended release Chemical Drugs(4) New Drug Application 2002-02-23 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Certificate Issued 2003-07-25 view
CXL01C36G 甲磺酸加替沙星片 gatifloxacin mesylate Tablet Chemical Drugs(2) New Drug Application 2001-12-31 南京振华医药科技开发有限责任公司 Nanjing Zhenhua Pharmaceutical Technology Development Co Ltd Approval Completed-Pending Certificated 2003-03-07 view