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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS20020805 注射用利巴韦林 ribavirin Lyophilized Chemical Drugs(4) New Drug Application 2002-09-02 上海新亚药业有限公司山东基恩医药研究有限公司 Certificate Issued 2003-05-30 view
CXL20021718 复方盐酸二甲双胍片 glibenclamide;metformin hydrochloride Tablet Chemical Drugs(4) New Drug Application 2002-07-30 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-06-06 view
CXL01C83G 西尼地平片 cilnidipine Tablet Chemical Drugs(2) New Drug Application 2001-12-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-09-05 view
X0401636 巴洛沙星 balofloxacin Active ingredient Chemical Drugs(3.1) New Drug Application 2005-01-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-04-11 view
CXL20022939 甲磺酸帕珠沙星 pazufloxacin mesylate Active ingredient Chemical Drugs(2) New Drug Application 2003-10-21 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-03-05 view
CXL01M02 富马酸伊布利特 ibutilide fumarate Active ingredient Chemical Drugs(2) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Approval Completed-Pending Certificated 2003-03-07 view
CXL20022936 注射用雷替曲塞 raltitrexed Lyophilized Chemical Drugs(2) New Drug Application 2003-11-11 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-04-02 view
CXL20020468 注射用盐酸尼莫司汀 nimustine hydrochloride Lyophilized Chemical Drugs(4) New Drug Application 2002-03-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-07-21 view
X0304914 利拉萘酯 liranaftate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-04-30 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-07-29 view
CXL20022933 注射用盐酸多西环素 doxycycline hyclate Lyophilized Chemical Drugs(4) New Drug Application 2002-11-13 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-08-25 view
CXL01E64 氯雷他定片 loratadine Tablet Chemical Drugs(4) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Approval Completed-Pending Certificated 2003-01-30 view
CXHL0502189 盐酸度洛西汀 duloxetine hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2006-01-05 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2008-07-22 view
X0300888 注射用头孢他啶他唑巴坦钠 (4∶1) ceftazidime;tazobactam sodium Lyophilized Chemical Drugs(1.5) New Drug Application 2003-11-04 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-04-29 view
CXL20022937 多非利特 dofetilide Active ingredient Chemical Drugs(2) New Drug Application 2003-12-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-05-28 view
X0401635 巴洛沙星片 balofloxacin Tablet Chemical Drugs(3.1) New Drug Application 2005-01-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-04-11 view
CXL20022940 甲磺酸帕珠沙星氯化钠注射液 pazufloxacin mesylate Injection Chemical Drugs(2) New Drug Application 2003-10-21 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-03-05 view
CXL01G11 利塞膦酸钠 risedronate sodium Active ingredient Chemical Drugs(2) New Drug Application 2002-02-22 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-08-01 view
CXL20022935 雷替曲塞 raltitrexed Active ingredient Chemical Drugs(2) New Drug Application 2003-11-11 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-04-02 view
CXL20020467 盐酸尼莫司汀 nimustine hydrochloride Active ingredient Chemical Drugs(4) New Drug Application 2002-03-18 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2003-07-21 view
X0304915 利拉萘酯软膏 liranaftate Ointment Chemical Drugs(3.1) New Drug Application 2004-04-30 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2004-07-29 view