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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL0500215 注射用伏立康唑 voriconazole Lyophilized Chemical Drugs(3.1) New Drug Application 2005-02-21 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2006-08-04 view
CXHL0500396 伏立康唑胶囊 voriconazole Capsule Chemical Drugs(3.1) New Drug Application 2005-03-26 山东基恩医药研究有限公司 Shandong Keen Pharmaceutical Research Co Ltd Certificate Issued 2005-12-02 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
CXHL0502190 盐酸度洛西汀肠溶微丸胶囊 duloxetine hydrochloride Capsule 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
CXHL0502262 米格列奈 mitiglinide 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 2008-07-15 view
CXHL0502263 米格列奈片 mitiglinide Tablet 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 2008-07-15 view
CXL01C82G 西尼地平 cilnidipine Active ingredient 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
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
CXL01E63 氯雷他定 loratadine Active ingredient Chemical Drugs(4) New Drug Application 2002-01-21 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
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
CXL01E65 氯雷他定胶囊 loratadine Capsule 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
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
CXL01G12 利塞膦酸钠片 risedronate sodium Tablet 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
CXL01G13 利塞膦酸钠胶囊 risedronate sodium Capsule 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
CXL01M01 西尼地平胶囊 cilnidipine Capsule 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 2003-08-25 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
CXL01M03 富马酸伊布利特注射液 ibutilide fumarate Injection 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
CXL20020464 盐酸托烷司琼 tropisetron 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 2003-06-20 view
CXL20020465 盐酸托烷司琼注射液 tropisetron hydrochloride Injection 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 2003-06-20 view
CXL20020466 盐酸托烷司琼胶囊 tropisetron hydrochloride Capsule 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 2003-06-20 view